Patent medical specialties are the merchandises that are invented by the company. who have their ain research squad working on their ain research labs. These merchandises are patented for many old ages to bask the monopoly market. After old ages of concern the preparation is sold in the market so that others can travel into mass production.
Generic medical specialties are the merchandises that are produced in mass graduated table. These are marketed by several companies under different trade name name. where the preparation of this merchandise is about same. Monetary values of the merchandises are under this class are competitory. Bangladesh chiefly concentrates on this class. as labour cost is one of the lowest in the universe.
Growth & A ; Tendencies:
The growing potency of pharmaceutical industry is tremendous. As urban population is increasing and people are acquiring educated. they are now more concerned about health care. So the demands of medical merchandises are lifting. In Bangladesh unhygienic conditions and hapless wellness care programs provide vast range for the pharmaceutical houses to sell their merchandises. On the other manus. the changeless natural catastrophes provide chances to pharmaceutical companies to hike its gross revenues. The industry is turning the protection of national Drug Policy 1982. But after the GATT ordinance. alterations are bound to take topographic point. Furthermore. the tendency & A ; growing of this industry tends to be positive as the demand of medical specialties is lifting. which have mentioned earlier.
HEALTHCARE AND PHARMACEUTICAL SECTOR: AT A GLANCE
Entire Area of Bangladesh 147. 570 Sq. Km
Population more than 133. 40 million
Crude Birth Rate ( CBR ) 19. 00 ( per 1000 )
Crude Death Rate ( CDR ) 4. 90 ( per 1000 )
Per Capita Annual Income ( CAI ) 470 ( in US $ )
Entire National Export 6. 889. 30 million US $
Entire National Import 10. 903. 00 million US $
Number of Countries Exported ( P/ merchandises ) 62 nos.
Entire Number of Registered P/Industries 235 nos.
Entire Number of P/Industries in operation 154 nos.
Entire Market Size 697 million US $
Percentage of Production of Local Industries 96 %
Percentage of Import against local market 4 %
Number of drugs produced by local P/C 450 generic points
Number of drugs controlled 117 generic points
Number of drugs decontrolled 333 generic Items
Number of drugs largely demanded 50 generic Items
Number of Industries bring forthing natural stuffs 21 companies Number of API being produced 41 Items
Drugs produced in generic Name 450 points
Drugs produced in trade name Name 5. 000 points
Drugs produced in strength ( figure ) 8. 000 points
Contribution to the gross sector 5. 00 US $
Contribution to the GDP 1. 25 per centum
Entire Employment Creation ( more than ) 78. 000 nos.
Number of Accredited Chemist ( Drug marketer ) 68. 000 nos.
Number of Chemist without License 52. 000 nos.
In economic sciences a country’s factor gift is normally understood as the sum of land. labour. capital and substructure that a state or industry possesses and can work for fabrication. Industries with a big gift of resources tend to be more comfortable than those with a little
gift. The development of sound establishments to entree and equitably administer these resources. nevertheless. is necessary in order for an industry to obtain the greatest benefit from its factor gift. However. the new universe economic systems inherited attractive gifts such as ideal conditions status. suited size of the industry or adept work force. In instance of pharmaceutical industries in Bangladesh. they have invested in land to increase their concern widely within and across the state. Day by twenty-four hours this sector is doing a random physical alteration to hold on the international market. All the companies in Bangladesh have enlarged their physical size with immense success. Pharmaceutical companies have besides appointed a big figure of skilled work force for the improvement of this sector. A immense sum of people have been trained good to successfully run the pharmaceutical companies around the state and outside every bit good. Demand:
Bangladesh is prone to tropical diseases. and this leads to a high demand for pharmaceutical goods. Because of this and the hapless wellness and hygiene state of affairss. a steady growing in the pharmaceutical sector is possible. Demand is positively related to the alterations in disposable income. Assuming that income per capita will go on to increase. it may be predicted that the demand for pharmaceuticals will besides go on to lift.
Dhaka is the largest subscriber. with about 35 % market portion. Chittagong and Sylhet follow with 26 % market portion each. Khulna has a much smaller portion of 14 % . but it has an huge growing potency because of the higher value gross revenues per chemist.
Dhaka besides has the highest per capita outgo on drugs. Surveies have shown that people in urban countries tend to devour more pharmaceutical merchandises compared to people populating in rural countries.
Urbanization is steadily increasing in Bangladesh. as more and more people move in from rural countries to populate in Dhaka and the other metropoliss. Because of the increased frequence in natural catastrophes. people prefer to populate and work in metropoliss other than in small towns. This bears a direct impact on the volume of gross revenues of the pharmaceutical companies. As more people are populating in
comparatively developed countries. the demand for medical specialty is besides lifting. This provides a great chance for the companies to increase their gross revenues.
Market chances and market entry scheme
1. Macro economic environment
The overall macro economic environment is rather positive and favourable for international concern. Both import and export are increasing ; import is increasing since the state has moved to fabricating sector more sharply due to handiness of skilled and cheaper labour force. In order to transport out international concern swimmingly. the national information substructure ( NII ) has besides improved. The authorities has introduced broad policy to pull for the foreign investors. concern and commercial organisations. The state is sing slow but steady growing in the Gross Domestic Product ( GDP ) at 5. 33 % . Cardinal indexs of gradual betterment in the economic system are positive ; Per capita income has increased at US $ 470 ( June 2005 ) . literacy rate has increased at 65 % . mean life anticipation rate has increased at 68. 2 old ages. one-year export growing is 9. 39 % while import grew merely at 13 % . Inflation rate has reduced at 5. 1 % . Per capita outgo on medical specialty has increased at more than US $ 4. 00. which is among so lowest in Asiatic states. compared to developed states. But. this indicates good potency for the growing of domestic market. The pharmaceuticals sector is a growing sector as mentioned in the earlier chapters. Future potency for this sector is besides bright. Recent export public presentation has drawn the attending of the authorities. But. the pharmaceutical industry sector is to a great extent depended on imported natural stuffs. Rapid growing in the export market has created chance to spread out production capacity. The sector can be viewed at a glimpse from the attached sector profile
2. Handiness of selling services
In Bangladesh. all sorts of selling and market publicity services are availability. There are marketing companies who can take up assignment of selling and distribution of merchandises overall the state. A big pool of gross revenues force has been developed over the last 22 old ages who can take the merchandises to the doorsill of the terminal users through 120. 000 retailed
Pharmacists. To form a gross revenues and selling force. expert services can be taken from local beginning. Furthermore. there are marketing and promotional bureaus. distributers. indenters and stockiest. Organizations are at that place to import accomplishment development preparation on gross revenues. selling and distribution. There are trade diaries. intelligence letters and trade bulletins specifically for the pharmaceuticals sector. There are a good figure of event organisers who can form trade carnivals. exhibitions and other events.
3. Recommended scheme for new entrants
Following the success narratives of the taking companies. several factors have been considered as critical to success and these are follows:
• Quality merchandise through quality production system
• Skilled and trained work force for merchandise publicity
• New and broad scope of merchandises
• Advanced promotional techniques.
• Strong rearward linkage support with or outside the state • Prompt and cost effectual bringing and distribution web with terminals • Attractive wadding and packaging with elaborate specifications • Continuous research and development for betterment of merchandises • Sound operational program including selling and fiscal planning
In the yearss to come. the local market will be really competitory. A new company should be good prepared with all kinds of be aftering like selling and publicity. procurance and production. distribution and bringing. sound fiscal direction. advanced merchandise development. A good combination of several major elements may convey success for any new entrant in this sector and these are as follows:
( a ) Merchandise features
154 companies are selling common merchandises. such tablets. capsules. sirup ( liquid ) etc. To achieve competitory border. new entrant should emphasis on new dose signifiers like. Anti-biotic. drugs. inhalator. suppositories. needle free injection. piece injection etc. Herbal merchandises have a big possible market.
( B ) Monetary value
Since the authorities purely controls monetary value of pharmaceutical merchandises. a new company should follow ‘shadow or indirect’ pricing method.
( degree Celsius ) Trade channel
New companies should follow trade channels that minimize their distribution and other costs. Possibility should be explored to acquire institutional orders. Contract fabrication can be one of the options since the revised policy allows it.
( vitamin D ) Promotion
Since direct merchandise publicity activities are prohibited other agencies should be applied. Push selling system can be an effectual technique for merchandise publicity. Besides. inducements in different signifiers may be given to the field degree gross revenues force. physicians and medical practicians. Sponsoring assorted events like workshops. seminars on medical specialties and health care related issues and financing charitable health care activities can be adopted.
( vitamin E ) Joint venture agreements
Joint venture agreement with foreign reputed pharmaceutical companies holding works for API perchance organize USA. Europe-Scandinavian states. Japan will be best option for any new entrant.
( degree Fahrenheit ) Buy out and amalgamations
Recently. many MNCs merged. In Bangladesh. there are hibernating mills which can be bought and restarted through inculcating fresh financess.
Related industries of pharmaceutical companies:
Pharmaceutical industry itself is a possible 1 in Bangladesh. There are besides some back uping sectors aboard this 1 in our state:
Strengths. failings. chances and menaces:
The strategic analysis on the pharmaceuticals industry of Bangladesh gives the undermentioned consequences: Strengths of the industry are as follows:
• 5-7 taking companies are universe category
• Products acceptable in the planetary market as ‘Quality Products’ • Wide scope
• Price is competitory both in local and foreign market
• Strong trade name image created by the market leaders parallel to MNCs • Large pool of efficient and qualified proficient work force at minimal cost • Supportive authorities policy pulling foreign investors • Do non hold to follow with IPR until 2016.
• Backward linkage support is being created
• Large domestic market with sensible growing
• Oldest and one of the largest sector in footings of capital investing Failings of the industry are as follows:
• Dependency on imported natural stuffs or absence of API workss • Absence of international standard quality control and proving research lab • Absence of bio-equivalence testing and clinical installations • Inadequate cognition on TRIPS and trade related affairs
• Little research and development on new molecule development
Opportunities for the Industry are as follows:
• Large potency for export market enlargement from 2006 boulder clay 2016 • Huge potency to set-up fabrication works for API or majority drugs • Broad authorities policy for the foreign investors for joint venture pharmaceuticals unit • Large pool of qualified proficient forces may put up fabricating units in other LDCs • Local companies can offer proficient know-how to LDCs for puting workss. • Domestic market is bit by bit increasing with the addition in GDP • Scope for merchandise variegation into herbal and carnal health care. • Research and development activities may be initiated with external support • Scope to take advantage of compulsory licensing. parallel import and bolar commissariats
Menaces for the industry are as follows:
• Cheaper medical specialty from China and India
• TRIPS may convey tough competition in the local and export market • India has amended 1970 Patents Act every bit favourable as possible • The sector is dependent on imported natural stuffs any fluctuation in natural stuff monetary values
or rate of exchange will hold negative affect on competitory monetary values. • Entry of transnational with big scale investing with strong backward linkage support • Neighboring states providing merchandises to Bangladesh through unauthorised channel. • Imported drugs will be in the local market after passage of revised drug policy
Population groups that have been conventionally defined along racial and cultural classs comprise of import subgroups whose particular demands and drug responses traditionally have been undervalued or ignored. The factors finding population fluctuations in response to medicines are complex and interdependent. Environmental factors ( e. g. . clime. smoke. intoxicant ingestion ) may hold a profound consequence on drug metamorphosis. Biological factors such as familial polymorphisms ( of course happening fluctuations in the constructions of cistrons. drug metamorphosis enzymes. receptor proteins. and other proteins involved in drug response or disease patterned advance ) . age. and gender have important influence and may necessitate the usage of surrogate drugs or doses in patients of different racial and cultural backgrounds. Familial research in the past few decennaries has uncovered important differences among populations in the metamorphosis. clinical effectivity. and side consequence profiles of therapeutically of import drugs. Yet cultural differences besides have been documented to impact a patient’s attachment to. and hence the effectivity of. drug therapy. For illustration. trust and regard for patients and their wellness beliefs and patterns. every bit good as communications issues. have been found to act upon attachment to medicine regimens. Patients’ beliefs about the nature of disease. credence of side effects. and penchants sing herb tea or traditional therapies may be influenced by a scope of socio-cultural influences. including gender. socioeconomic category. instruction. immigrant position. and faith. all of which must be taken into history. Additionally. communications barriers may take to wrong readings of diagnosings and instructions sing intervention. Similarly. unequal wellness literacy may impact the ability to understand and follow through on wellness information affairs.
Direct-to-Consumer ( DTC ) Ad is a signifier of selling in which advertizements for pharmaceutical merchandises are aimed straight at consumers. in add-on to medical suppliers and remunerators. The treatment around DTC is centered on whether direct-to-consumer advertisement provides value for consumers. prompts appropriate usage. and whether it increases diagnosing of otherwise unmarked medical jobs. To turn to turning concerns about DTC advertisement. PhRMA approved and released voluntary guiding rules for industry to follow in developing DTC advertisement. Cardinal elements include: * Submiting all advertizements to the FDA prior to air ; * Transparency sing what the advertised medicine is intended to handle ; * Balanced presentation of hazards and benefits ; and
* Educating attention suppliers about a medical specialty before making out to consumers.
Disease Management and Medicaid Health Outcomes Management
Cost containment of pharmaceutical outgos normally involves assorted attempts to command drug use. These attempts typically are aimed at physician suppliers. druggist suppliers. or the pharmaceutical industry. They have included the constitution of drug pharmacopeias and anterior mandate plans. Governmental statute law has had an of import function in determining these attempts. A comparatively new attack to be containment is disease direction. Disease direction refers to a system of co-ordinated wellness attention intercessions for populations with conditions in which patient self-care attempts are important. The end of disease direction plans is to optimise therapy. Optimizing therapy should better results and diminish overall outgos associated with a disease.
Drawbacks of Component Management
In wellness attention. component direction is the pattern of individually pull offing single cost drivers. such as prescription drugs. infirmary admittances and physician visits. alternatively of sing the implicit in wellness issues of patients or entire mix of characteristics in a wellness attention program. Through component direction. wellness attention programs try to take down overall costs by doing alterations specific to a cost driver. When prescription drugs are managed as a
separate constituent. for illustration. there is no consideration given to the effects of appropriate drug usage on the usage of other medical services. Restricting drug usage through pharmacopeias or higher carbon monoxide payments might ensue in lower use of medical specialties. but surveies have found that making so creates higher costs through increased hospitalization and other wellness jobs. Drug Spending Trends
Increased disbursement on prescription drugs is frequently attributed to higher monetary values for bing and new drugs. However. additions in disbursement besides are determined by the volume of prescription drugs taken by patients. which is defined as the figure of prescriptions and the figure of yearss for which a given prescription provides therapy. Research supported by the National Pharmaceutical Council developed the methods needed to place the specific monetary value and volume factors responsible for increased drug disbursement. This research found that increased usage of prescription drugs due to better diagnosing of disease. new medical recommendations for intervention. and in some instances. newer. more effectual medical specialties may play a larger function than additions in monetary value in explicating increased disbursement tendencies.
Scheme of runing pharmaceutical industry:
The pharmaceutical industry is the world’s largest industry. Pharmacy industry has seen major alterations in the recent old ages that place new demands on remunerators. suppliers and makers. Customers now demand the same pick and convenience from pharmaceutics industry that they find in other section. Bangladeshi Pharmaceutical Industry is poised for high consistent growing over the following few old ages. driven by a battalion of factors. Top Bangladeshi Companies like Square. Opsonin and Beximco have already established their presence. The pharmaceutical industry is a cognition driven industry and is to a great extent dependent on Research and Development for new merchandises and growing. However. basic research ( Detecting new molecules ) is a clip consuming and expensive procedure and is therefore. dominated by big planetary multinationals.
While many pharmaceutical companies have successfully deployed a overplus of schemes to aim the assorted client types. recent concern and client tendencies are making new challenges and chances for increasing
profitableness. In the pharmaceutical and healthcare industries. a complex web of decision-makers determines the nature of the dealing ( prescription ) for which direct client of pharmaceutics industry ( physician ) is responsible. Basically. the end-user ( patient ) consumes a merchandise and pays the cost. Use of medical representatives for selling merchandises to doctors and to exercise some influence over others in the hierarchy of determination shapers has been a tried tradition. Typically. gross revenues force disbursal comprises an estimated 15 per centum to 20 per centum of one-year merchandise grosss. the largest line point on the balance sheet. Despite this other expense the industry is still plagued with some really serious strategic and operational degree issues. From organisational position the most outstanding public presentation related issues are enlisted below: a ) Increased competition and shortened window of chance. B ) Low degree of client cognition ( Doctors. Retailers. Wholesalers ) . degree Celsius ) Poor client acquisition. development and keeping schemes d ) Changing client perceptual experience.
vitamin E ) The figure and the quality of medical representatives.
degree Fahrenheit ) High preparation and re-training costs of gross revenues forces.
g ) Very high abrasion rate of the gross revenues forces.
H ) Busy physicians giving less clip for gross revenues calls.
The pharmaceutical industry is characterized by heavy R & A ; D outgo. It is merely the big pharmaceutical companies who can apportion important resources for R & A ; D to present new merchandises. As the merchandises are results of important R & A ; D expenditures incurred by these companies. they have their merchandises patented. The patent allows the companies concerned to exert huge pricing power for their new merchandises. What’s the secret behind these successes? For one. the company operates in niche preparations ( chronic ) sections such as psychopathology. cardiovascular. gastroentology and neurology. While most of the top Bangladeshi companies have focused on antibiotics and anti– infectives ( ague ) . Aristo Pharma focused on curative countries such as depression. high blood pressure and malignant neoplastic disease. The company has introduced the full scope of merchandises and has gained leading place in each of these countries. Bing a forte. company insulates Aristo drug company from the industry growing. One of the invariables of pharmaceutical company scheme over the past decennary has been increasing graduated table.
Merely by turning larger are companies able to afford the considerable costs of drug development and distribution. Within this wide attack at least two concern theoretical accounts are discernible: ( I ) Super Core Model affecting the hunt for. and distribution of a little figure of drugs from Chronic Therapy Area that achieve significant planetary gross revenues. The success of this theoretical account depends on accomplishing big returns from a little figure of drugs in order to pay for the high cost of the drug find and development procedure for a big figure of patients. Entire grosss are extremely dependent on gross revenues from a little figure of drugs. ( two ) Core Model in which a larger figure of drugs from Acute Therapy Area are marketed to large diversified markets. The advantage of this theoretical account is that its success is non dependent on gross revenues of a little figure of drugs. Medical representatives are rearranged throughout the new companies. Some of the gross revenues representatives are now afraid of losing their occupation. due to the altering scenario and the possible ballad offs. On the other manus. the new. bigger. pharmaceutical companies are viing more and more with one another. and. in order to emphasize their merchandises. might follow a more aggressive gross revenues scheme. For illustration. sometimes in the same geographical country there are five representatives for merely one company. or different representatives for the same drug in different scenes. As a consequence of the new. aggressive scheme. the aggressiveness of representatives has besides been increasing. since the larger emphasis exerted by their companies might impact their stay in the company. Therefore. they tend to hold more frequent visits to promote physicians to order drugs and therefore increase gross revenues. Pharmaceutical selling is a specialised field where medical representatives form the anchor of full selling attempt. Pharmaceutical companies besides appoint medical representatives and delegate them defined districts. Medical representatives fitting physicians. chemists and stockiest as per company norms. Medical representatives try to act upon prescription form of physicians in favour of their trade names.
There is enormous potency for the export of medical specialty from Bangladesh to go a turning. dining concern. The pharmaceutical sector has a big possible market abroad. Drugs produced in the state commands high demand
in the foreign markets as the sector maintains high quality.
Policy dramas of import function in hiking any industrial sector and that has happened to the pharmaceutical industry of the state. 1982 is considered as a landmark in the pharmaceutical industry history of Bangladesh when a new Drug Policy was formulated in the twelvemonth. The aim of the policy was to go autonomous in the pharmaceuticals sector to supply indispensable drugs to patients at an low-cost cost. to uphold consumers involvement by supplying them effectual and quality drugs. Drug Policy was found extremely successful in accomplishing about all its declared aims. In fact. Bangladesh was the first and the innovator in explicating such a policy in the line with the guidelines for indispensable drugs as recommended by the World Health Organization ( WHO ) .
The Drug Policy is under reappraisal to run into the demands of the present clip. Harmonizing to the Minister. Ministry of Health and Family Welfare. Dr. Khandaker Mosharraf Hossain. the bill of exchange has already been proposed. To his sentiment the reviewed policy will further ease the growing of the pharmaceutical sector. ( Beginning: The Business Bangladesh. March 2004 )
Bangladesh is now about a self-sufficing in its pharmaceuticals sector as 97 % of the state drug demand is met by local makers. With the success in the domestic market topographic point the Bangladesh Pharmaceutical Industries are now trying to come in into the international market.
Strength and failings of Bangladeshi P/companies
In general. Bangladeshi pharmaceuticals companies are now stronger in footings of quality merchandise. attractive design. safe wadding. timely bringing. and competitory monetary value. Almost every good company has ISO certification and sound quality control system run by qualified staff. The taking companies are keeping international criterions in all domains of their concern activities. Several companies are of universe criterion and merit strong fight in the universe market. Main failing with the local companies is the dependence on the imported natural stuffs. Research and development demands to be progressed farther for long term sustainability.
1. Merchandise design
Although merchandise design varies from company to company. but the prima local and foreign companies have certain criterion on merchandise designing that is acceptable to universe market. They use choice design of battalions. strips. bottle cover etc.
Top 25 companies are bring forthing merchandises of international criterion and all makers follow Gross Manufacturing Practice ( GMP ) .
3. Monetary value
Since the local authorities purely controls monetary value of pharmaceutical merchandises. there is a really negligible monetary value difference. The maximal retail-selling monetary value of a merchandise shall be merely double the monetary value of API plus value added revenue enhancement at15 % VAT. But. the monetary value of natural stuffs is competitory which is fixed based on international market state of affairs.
Footings and conditions of gross revenues are about same for every company. since the net income border is about same for every merchandise. Usual price reduction for the traders/retailers’ degree is 12-15 % for local Formulations and 10-12 % price reduction for imported Formulations. Some companies offer particular price reduction to the bargainers that ranges from 2. 5 % to 7. 5 % . Provision of recognition gross revenues is non usual pattern.
Most companies deliver goods to the retail merchants and bargainers by their ain conveyance agreement as independent 3rd party distribution channel does non be.
6. Back-up services
Back-up services are at that place at retailers’ degree. Expired unsold merchandises are refunded at a certain per centum. Loss and amendss are besides compensated depending on the measure of medical specialty.
Market and gross revenues promotional activities are carried out by field degree gross revenues force. Every company has its ain gross revenues at local and international degree. Required conveyance installations are given to the gross revenues force in the field to see physicians. wellness attention centres. infirmaries and private practicians. Merely merchandise literature. tablet. diary. gifts. etc. are used during gross revenues calls. Adequate promotional stuffs are distributed to the practicing Doctors for their regular usage. Harmonizing to the local Torahs. advertizement on merchandises or trade names is non allowed through any media. Product advertizement can be published in the medical diaries provided there is anterior permission from the concerned authorization.
Tendency of export
Export of local pharmaceutical merchandises has experienced positive growing during the last one decennary. In fact. this has been a great accomplishment for the sector as a whole. which has been finally possible because of the authorities liberalisation policy including a favourable and contributing National Drug Policy in 1982. First export of pharmaceutical merchandises was made in 1972 and the sum was really undistinguished. Growth in the volume of export of pharmaceuticals was really slow boulder clay 1990. After 1990. the volume of export of pharmaceuticals had started turning and over the old ages. the volume has increased bit by bit. Increasing tendency in the export of pharmaceuticals has continued till this twelvemonth. During the 10 months ( July2003-April 2004 ) . Bangladesh made an export of US $ 8. 66 million and estimated export for the twelvemonth will be US $ 10. 39 million. At present. Bangladeshi pharmaceutical companies export to more than 50 states that include Bhutan. Myanmar. Cambodia. Hong Kong. India. Indonesia. Japan. Korea. Maldives. Nepal. Pakistan. Philippines. Singapore. Sri Lanka. Thailand. Vietnam. Brazil. Colombia. Egypt. Ethiopia. Finland. France. Ghana. Greece. Iran. Geordan. Kenya. Korea Republic. Mexico. Netherlands. Norway. Papua New Gini. Soudi Arabia. Sudan. Yemen. Djibuti. Senegal. Germany. USA. Oman. Russia. Ukraine. Austria. Australia. Belgium. Malawi. Malaysia. Middle East etc. Several companies have opened their abroad subdivision to advance export market.
Local pharmaceutical companies exporting merchandises are viz. . Beximco. Square. Jayson. ACME. Renata. Gonoshastha. Novartis. Eskayef. Essential Drugs Company Limited. Global Capsules. Navana. Maxfair. Millat. Skylab. Aristopharma. UniMed and Unihealth. Modern. Beximco Infusion. Opsonin. Drug International. Medimet. ACI. General. Nipa and Aventis. Major growing in export of pharmaceuticals has been achieved in the participating states those who are traveling to go to the Asia HealthCare 2004. States that are importing merchandises from Bangladesh are viz. . Vietnam. Philippines. Thailand. Singapore. Sri Lanka. Malaysia. Indonesia. Cambodia. China. Nepal. India. These states import pharmaceutical merchandises from Bangladesh on regular footing. although the measure of import is non really important.
Although the authorities has formulated favourable policies. the exporters of pharmaceutical still face the undermentioned restraints and hindrances: • Allocation of unequal disbursals for runing foreign gross revenues office • Registration in the importation States
• Delay in issue of the FSC Issue of “Free Sale Certificate” by the Regulatory Authority • Lack of inducement for Export
• Customs fuss for cargo of Samples
• Absence of Data Base on Importers and Exporters.
• Troubles in happening dependable Distributors/ Agents
• Unreasonable duty infliction
• Lack of Information on Importing Countries on affair associating authorities formalities. Registration demands.
Existing export development programs
Some 27 local pharmaceuticals companies are on a regular basis exporting from Bangladesh and all of them have one-year export development programs. New companies are be aftering to come in into export market and developing their export programs. Individual companies initiate their export publicity activities. So far. the authorities or the trade publicity office’s part to advancing export market was negligible. Individual companies
advance their merchandise through take parting in the international Trade carnivals and Exhibitions of pharmaceutical merchandises. distribute merchandise literature and visit to the prospective foreign purchasers and agents. The bing exporters apply the following techniques for export market development: a ) Attending trade carnivals. buyers/sellers run intoing
B ) Meeting with the Representatives of the local concern communities. trade associations and Chamberss
degree Celsius ) Keeping clinical meetings
vitamin D ) Meeting the functionaries of the commercial subdivisions of the Embassy vitamin E ) Meeting the functionaries of the concerned regulative authorization. The exporters besides take the undermentioned promotional steps for trade publicity: a ) Incentive to the local agents
B ) Inviting local agents for gross revenues meeting in the state
degree Celsiuss ) Puting up marketing office in the abroad
vitamin D ) Contacts with the regulative authorization and the ministry
vitamin E ) Sponsoring engagement of seminar of Doctors in Bangladesh degree Fahrenheit ) Distribution of literature
Export inducements provided by the Government
There is no proviso for hard currency inducements in Bangladeshi pharmaceuticals exporting. Recently. this issue has been repeatedly discussed within the stakeholders and they are actively prosecuting for this hard currency inducement in order to stay competitory in the export market. So far. the bing Export Policy of the authorities offers inducement that is applicable to all exporters including pharmaceutical companies: a ) Value added revenue enhancement at 15 % is exempted on the merchandises produced for export ; b ) Any single or organisation can use foreign currency for the intent of export of any merchandises
degree Celsius ) Tax is exempted in instance of corporate export income
vitamin D ) In instance of “Deemed Export” . VAT is wholly exempted
Apart from the above inducements. other inducements for export are:
a ) Export recognition warrant strategy for coverage to the exporter. B ) Export recognition warrant for pre-shipment
degree Celsiuss ) Export Credit warrant for station cargo
vitamin D ) Export payment Hazard policy ( Comprehensive warrant )
vitamin E ) Whole turnover pre-shipment finance warrant. The authorities has its plan but in world a few are being practiced.
degree Fahrenheit ) Currency transition installation ( taka ) under this system. Exporters are allowed to maintain foreign currency in their history g ) Foreign currency use installation
H ) Exporters are allowed to use foreign currency carved from the farther export intent. I ) Export Development fund: the fund will be utilized to supply aid to the local makers and for export selling. export variegation and development of export of non-traditional points. These include go toing seminar. made carnivals. puting up gross revenues centre in foreign state. J ) Extension of export recognition period from 180 yearss to 270 yearss. Time period of Export recognition under export development fund has been extended up to 270 yearss. K ) Export Financing: Credit card has been introduced to cut down hazard of transporting hard currency dollars by the exporters. cubic decimeter ) Limit of border of export has been increased up to 90 % i. e. any exporter can avail loan up to 90 % of the contract monetary value or L/C value. m ) Credit for new and fresh exporters is given if they apply. N ) Total flow O export recognition will be maintained.
O ) Export loan portfolio has been introduced by the cardinal bank to guarantee regular export funding. P ) Incentive will be given in instance of export of new industrial merchandises. Q ) 50 % of the entire export net incomes will be revenue enhancement exempted
R ) Duty draw back installation will be provided through commercial bank in order to maintain the market monetary value competitory. s ) Bonded warehouse installation for exported has been encouraged T ) Capital machinery may be imported without any revenue enhancement
U ) Tax vacation proviso shall be imposed by the authorities
V ) Sample for export: Limit for directing sample for trade carnival is US $ 2. 000 and other aim the bound is US $ 1. 500. Sending sample through package station is increased at US $ 59. 00 tungsten ) Re-export: Permission is non required from the MINISTRY of Commerce on instance to instance footing and VAT is reduced at 5 % from 10 % ten ) Export as that L/C: Merchandises can be exported on the footing of purchasing contract. understanding. and purchase order to progress payment. In this instance. the exporter has to subject EXP Form and transportation measure. Y ) Import or beforehand payment L/C: L/C will non be required in instance of import of capital machinery and basic natural stuffs and perishable point for re-export. omega ) Product Diversification Project: To maintain export monetary value at competitory degree. agreement shall be made for responsibility draw back and hard currency inducement for export.
No particular recognition installation or system exists for financing export of pharmaceutical merchandises. There was an “Export Credit Guarantee Scheme” for all kinds of exports under the control and supervising of the cardinal bank. but the public presentation was non satisfactory. The strategy was targeted for overall industrial sector. but non specifically for the export of pharmaceutical merchandises. However. the local and foreign Bankss working in Bangladesh have been back uping export activities of any sort through widening their foreign trade services.
Government policy on export
In general. Bangladesh authorities strongly encourages all sorts of export including Pharmaceutical merchandises. During the month of May 2004. the authorities revised ‘National Drug Policy’ in order to do it more contributing for the foreign investors every bit good as the local manufacturers be aftering to advance exports. Sing regulations and ordinances of export of pharmaceuticals. the country’s bing “Export and Import Policy” is followed. The authorities has plans to present more contributing policy to hike export of pharmaceuticals in close hereafter.
Trade publicity activities
1. Export development services
In Bangladesh. there is no particular trade publicity office or cell provinding export selling and publicity services for pharmaceutical sector. Export Promotion Bureau ( EPB ) is the lone public sector organisation specialized in widening assortment of export development and selling services to ease the local exporters of all sectors. EPB provides information on export market and organizes activities related to export selling and export market development. Besides. there is a a turning figure of private consulting houses that provides concern services including selling services. Persons are working as selling agent or distributers who explore export market for local companies. Local consulting houses are besides fixing the companies for export through quality enfranchisement and other direction development. It is expected that export development services will be developed in close hereafter as the state will bask tremendous benefits from the TRIPS after 2005.
2. Trade publicity activities
Recently. as mentioned earlier. the Ministry of Commerce and Export Promotion Bureau in coaction with the sector association of pharmaceutical companies i. e. BAPI have taken particular inaugural or plan for export publicity of pharmaceutical sector. Activities like forming trade missions and group visits to international trade carnivals. exposing pharmaceutical merchandises in Bangladesh pavillion abroad and forming buyers/sellers are the now on a regular basis organized by the Ministry of Commerce and Export Promotion Bureau and the trade organic structures including Federation of Bangladesh Chambers and Commerce and Industry ( FBCCI ) .
Possibilities in fiting criterion and monetary value in international market:
Now a yearss Bangladesh is a celebrated name in the international market for its criterion of pharmaceutical merchandises. Our pharmaceutical industry competes with international company. Bangladesh has been seeking to carry through the national aspiration of turning its pharmaceutical industry into an exporter of quality medical specialties. In mid-90’s a few companies took enterprises to export
pharmaceuticals from Bangladesh. Today. Bangladesh is exporting its pharmaceuticals to assorted states like Singapore. Russia. Ukraine. Georgia. Pakistan. Myanmar. Vietnam. Sri Lanka. Nepal. Kenya. Germany. Yemen. Malaysia. Iran. Philippines. Sudan. South Korea. Bhutan and Hong Kong. It is deserving adverting that the universe renowned infirmaries & A ; establishments like. KK Women & A ; Children Hospital and Raffles Hospital of Singapore. MEDS of Kenya and Zinnah Hospital of Pakistan have been utilizing the Pharmaceutical merchandises of Bangladesh. Because. Bangladeshi pharmaceutical criterion matched to the international criterion. Bangladesh has been exporting broad scope of merchandises covering about all curative categories and dose signifiers. Apart from exporting tablet. capsule. sirup. suspension etc. . it besides exports ‘High Tech and Specialized products’ like Metered Dose Inhalers ( MDIs ) . Nasal Sprays. Suppositories. Large Volume Potentials ( LVP ) and little Volume Potentials ( SVP ) . Bangladesh is now on the brink of come ining extremely regulated abroad markets like USA and Europe. In this connexion. three major pharmaceutical makers have already made immense investings in their new plants/factories. Price in international market for pharmaceutical merchandises is much higher than Bangladesh. Because our labour cost is lower than international sector. External monetary value referencing ( or international benchmarking ) stands to impact the monetary values and handiness of medical specialties outside the state set abouting the benchmarking pattern by cut downing manufacturers’ willingness to put monetary values harmonizing to national market conditions. This may hold a negative consequence on affordability and handiness of medical specialties in smaller markets and lower-income states. including lower-income states in the OECD.
The pattern of holding to confidential discounts can besides hold an external consequence. in that other states utilizing external benchmarking may cite unnaturally high monetary values. ensuing in list-price rising prices. Claw-backs have a similar impact in that they mean the monetary value is efficaciously changed post-purchase ( after the list monetary value has already affected the planetary monetary value through external benchmarking ) . The convergence in list monetary values of pharmaceuticals that has been observed in Europe ( including Switzerland ) and between European states and Canada is consistent with what would be expected in a market characterized by such patterns.
Mode of conveyances
All most all pharmaceutical companies procure natural stuffs through indenting houses. except a few large companies. Formulations are imported through the local agents of the foreign companies. But. there are besides direct Importers. Pharmacists and Chemists who import merchandises for trading intent. In instance of import of natural stuffs and finished merchandises. the local indenting houses and Clearing and Forwarding Agents play an of import function. In Bangladesh. the local importers of drugs and medical specialties are good organized. Footings and conditions of import of natural stuffs vary from merchandise to merchandise every bit good as makers. There is no limitation on measure and measure depends on the demands of single companies. There is no limitation on import of packing and packaging stuffs. Lead clip of import depends on state of beginning and manner of conveyances. In instance of Active Ingredients the proviso for safety border is 3-4 months ( by sea ) and 2 months ( by air ) . For Excipients safety border proviso is 6-8 months if the cargo is made by sea and 4 months ( by air ) . For Finished merchandises. it is 2-4 hebdomads. Four different manners of conveyance are being used for import and these are by air. by sea. by rail and by route. However. major parts of the imported stuffs are coming by sea. Usual point of entry is Chittagong ( 90 % ) and Mongla. For import of high power but light and dearly-won pharmaceuticals. the local importers use air path often. Some part of the import is besides coming by route through land boundary line chiefly from India
Packing and packaging stuffs
Packing stuffs used in the local pharmaceutical industries include aluminum foil ( blister & A ; strip ) . Alu alu foil. rubber stropper. flip-off seal. printing stuffs. fictile cap. injectible. tear-off seal. tubing. PVC. PVDC. degree. bottle ( white & A ; colour ) . fictile container. paper sketch. printing stuffs. packages. etc. Almost every packing stuff is locally available except aluminium foil. alualu foil. PVC. PVDC. colour bottles. etc are imported from states like Korea. Dubai. India. China and so on.
Import responsibility construction and footing of rating
Import responsibility and other revenue enhancements are charged on both Formulations and natural and
packing stuffs. Import responsibility on any active ingredient entirely used for pharmaceutical merchandises is 7. 5 % . In instance of commercial import. the import responsibility is 15 % . Value added revenue enhancement is collected at 15 % from all imports. but it is adjusted afterwards on the footing of existent production end product. Natural stuffs used for merchandises will be exported finally require no responsibility. Advance Income Tax ( AIT ) is besides charged but to be refunded subsequently. Cost. Insurance and Freight ( CIF ) monetary value of the stuffs to be imported is the footing of appraisal of import responsibility and other revenue enhancements. This may change in an exceeding state of affairs. In add-on to duty appraisal. duty value is besides imposed. Such duty value is assessed on the footing of the highest CIF value of natural stuffs being imported by other importers. Appraisal of duty value depends on the discretion of the imposts authorization. and it varies from instance to instance and it is a deciding factor of existent landed cost of any imported stuffs. In add-on. there is a proviso for Development Surcharge at 2. 5 % of the CIF value. Apart from this. every import incurs basic costs that include license fee ( 0. 25 % of the CIF value ) . L/C committee for opening missive of recognition ( 0. 3 % to 0. 5 % of the L/C value or minimum US $ 6. 5 ) . bank charges. and insurance premium at 1 % of the C & A ; F value of the stuffs to be imported. The Government Customs section through its designated functionaries assesses the value of import in “local currency ( Taka ) ” . based on the “invoice value” .
ABSTRACT OF NATIONAL DRUG POLICY ( REVISED ) 2005
1. Laws and ordinances
Relevant Laws and Regulations commensurate with the prevailing fortunes normally control and regulate production. distribution. sale and usage of drugs in a state and guarantee that they are of good quality. efficacious and safe. Presently. the Drugs Act. 1940 ( XXIII of 1940 ) and the Drugs ( Control ) Ordinance. 1982 ( Ordinance No. VIII of 1982 ) modulate the procedure of enrollment. industry. distribution. sale. import and export of drugs in Bangladesh. These drug regulative legal instruments of the state are now rather old. Recently. the drug policy 1982 has been revised through necessary amendments to maintain gait with newer developments in the drug sector. Similarly. the Rules made under the above Act and Ordinance should besides be
updated and integrated into one set of Rules.
If the operation of these Torahs and ordinances and their compatibility with other Torahs. either under the duty of the Ministry of Health & A ; Welfare or other Ministries and Departments. affect execution of the different facets of the NDP. they should be amended consequently.
2. Drug Regulatory Authority ( DRA )
A strong administrative set-up is indispensable for effectual direction of the assorted facets of the drug sector of a state. The Directorate of Drug Administration of Bangladesh has been proposed to beef up to efficaciously execute the assorted maps of the regulative authorization. The undermentioned steps have been taken:
I. The position of the Directorate of Drug Administration ( DRA ) raised to that of the Directorate General of Drug Administration ( ( DGDA ) with matching addition in its work force and infra-structure installations.
two. The organgram of the DGDA accommodates all lawful systems of drugs and modulate them under unified control.
three. The regulative duties has been decided to be delegated to different managers under DGDA to hasten and ease the functional procedures.
four. The decision-making procedures will be guided by the nonsubjective. non-discriminatory and crystalline guidelines and processs.
v. The staff of the DGDA will be adequately trained. have clearly defined maps and powers. and be entrusted with duty in relation to all facets of enrollment. industry. storage. distribution. sale. import. export and quality of drugs in order to guarantee conformity with the Torahs. regulations and ordinances.
3. Drug enrollment
All drugs and medical specialty and other medicative substances in finished dose signifiers. which are manufactured. imported. distributed. marketed or consumed in the state must be registered with the Drug Regulatory Authority ( DRA ) of the state in the specific dose signifier and strength as recommended by the Drug Control Committee ( DCC ) .
a ) Choice of drugs for enrollment
( I ) Choice of a drug either for industry or import is one of the of import maps of the National Regulatory Authority ( NRA ) . For this intent the current system of holding a drug enrollment consultative commission ( DCC ) . which comprises of experts and professionals from assorted subjects. will go on.
( two ) Quality. safety. efficaciousness and utility will ever be the predetermining standards for blessing for sale of pharmaceutical merchandise.
( three ) The Directorate General of Drug Administration. with blessing of the DCC. shall choose and do lists of Essential and Non-Prescription ( OTC ) drugs following the WHO Guidelines and Model lists of such drugs clip to clip.
B ) Registration standards
( I ) As a general rule. enrollment for industry. import and sale of combination drugs other than those of Unani. Ayurvedic & A ; herbal readyings. vitamins and nutritionary readyings should non be allowed in the state. However. combinations like vitamins. nutritionary readyings and other drugs which are therapeutically utile and are registered in the developed states. could be considered for enrollment. In instance of the Homeopathic system besides. enrollment for industry. import and sale of combination medical specialties shall non be by and large allowed.
( two ) In instance of imported allopathic drugs. the fabrication site will be inspected for GMP proof by the inspectors of the drug regulative
authorization of Bangladesh. The reviews will be scheduled by the DRA and the concerned makers will bear the cost of any such review. However. the reviews will non be a saloon to the consideration of a new drug application manufactured in a developed state included in the list of the Licensing Authority.
( three ) Bioavailability and bioequivalence informations will be considered as of import standards for the enrollment of any imported medical specialty.
( four ) Any Unani. Ayurvedic or Herbal drug included in the pharmacopeia of other states. if considered indispensable and utile by the National Unani. AYURVEDIC & A ; Herbal formulary Committee. may be granted enrollment for industry and sale in the state. National Unani. Ayurvedic & A ; Herbal Formulary Committee will be constituted by the authorities with the experts on Unani. Ayurvedic and Herbal drugs.
( V ) Single enrollment for Mother Tinctures. Mother Triturations and 12 bio-chemic and their 1X authorities of the homeopathic system may be allowed.
( six ) Biochemical merchandises will be registered by the Licensing Authority ( Drugs ) based on their safety. quality and utility.
( seven ) Liquid dose signifiers of unani. ayurvedic and herbal ayurvedic and herbal drugs that contain up to 5 % ( v/v ) of 96 % ethyl alcohol may be allowed to be registered. if usage of such high proportion of ethyl alcohol is perfectly needed for their better efficaciousness and maintaining quality. However. in exceeding instances. usage of ethyl alcohol up to a maximal volume of 10 % ( v/v ) may be allowed. if recommended by the DCC.
( eight ) Certain drugs. in malice of their known serious side-effects and possibility of being misused. may be registered for import. production and sale in limited measures for restricted usage.
degree Celsius ) Registration process
The current processs adopted for enrollment of drugs of all the
recognized systems. as specified in the bing Torahs. should go on after modifying or upgrading them as appropriate. But. attempts should be made to develop methods for hastening the procedures of enrollment.
4. Drug production
( I ) One of the chief aims of the NDP is to bring forth good quality drugs in the state. The current Good Fabrication Practice ( cGMP ) guidelines of WHO should therefore be purely followed in the industry of drugs in the state. In order to guarantee rigorous conformity with the demands of cGMP. all drug production units should be capable to regular review by the Inspectors of the Directorate of Drug Administration. The makers will besides be expected to carry on periodic internal cGMP audit following the standard “Check-list” of the Directorate of Drug Administration.
( two ) Another chief aim of the NDP is to guarantee autonomy in all types of drugs. Therefore. all necessary steps should be undertaken to guarantee that the current tendency of increased rate of local production of drugs is sustained and further improved.
( three ) Precedence should be given to production of equal measure of indispensable drugs. Attempts would be made to guarantee that all the indispensable drugs and non-prescription ( OTC ) drugs ( lists f which are appended to this policy ) are manufactured in the state in sufficient measures and they are available at low-cost monetary values.
( four ) Foreign and transnational companies will be allowed to put and fabricate drugs in Bangladesh every bit long as they have at least three of their original research merchandise. Drugs registered in at least two of the undermentioned states: USA. UK. Switzerland. Germany. France. Japan and Australia.
( V ) Industry of drugs that are non included in the last five editions of the British or United States Pharmacopoeia ( USP ) or International Pharmacopoeia ( IP ) or the British Pharmaceutical codex ( BPC ) ; or in the WHO lists of the International Non-proprietary Names ( INN ) . will be prohibited.
( six ) In order to promote transportation of engineering and handiness of the freshly developed drugs. foreign companies. with or without holding fabrication workss in Bangladesh. will be allowed to fabricate drugs in the state under licencing understandings with any spouses of their pick.
( seven ) The undertaking of bring forthing Unani. Ayurvedic and Herbal drugs will lie entirely with national makers with a position to achieving self –sufficiency in regard of local resource based drugs.
( eight ) Both local and foreign companies holding fabrication workss in Bangladesh will be allowed to makers drugs under toll / contract fabricating agreements at any other fabrication workss o their pick.
( nine ) For the intent of export merely. any drug may be allowed to be produced in the state in conformity with the specific demands of the importing state.
5. Drug procurance
( I ) Drugs and pharmaceuticals may be procured by local purchase or import. and by having as contribution or gift.
( two ) Drugs for personal usage of single patients or to run into any national exigency state of affairs or for the intent of research and clinical tests or for any other specific usage. which are non registered. may be imported with anterior blessing of the Licensing Authority ( Drugs ) for specific measure and for non-commercial intent.
( three ) Importing of a drug that is produced in the state in equal measure will non be allowed as a step of protection for the local industries. However. if local production of any drug falls short of demand for any ground. or in instance of exigency arises. this status may be relaxed by the Government for a specified period.
( four ) Any basic pharmaceutical natural stuff. which is locally manufactured in sufficient measure. will be given protection by forbiding import of this
natural stuff or its replacement in the state. However. if needed for export intent. importing of such pharmaceutical natural stuffs will be allowed in competitory monetary values through international stamp.
6. Drugs distribution. sale and storage
Prompt and safe distribution and ethical sale of drugs from public/ private storage installations to the terminal –users should be ensured so that the quality of the merchandises is maintained throughout the whole procedure and good quality indispensable drugs are ever available to those who need them.
( I ) Merely the drugs. which are registered in Bangladesh. should be allowed to be distributed and sold in the state.
( two ) No Person without holding professional making or keeping valid professional licence should be allowed to stock. distribute or sell drugs and medical specialties.
( three ) No drugs or medical specialties. other than non-prescription ( OTC ) drugs. should be sold or dispensed without prescriptions.
( four ) Care of quality and safety of drugs in retail mercantile establishments and in storage should be ensured by transporting out regular cheques by Inspector of drugs on the quality of stored drugs at all degrees.
7. Drug pricing
( I ) Rational pricing of drugs should be ensured to do indispensable drugs available to the endusers at low-cost monetary values.
( two ) The current system of commanding monetary values of normally used indispensable drugs should be continued and the bing list of the prices-controlled drugs should be updated in the visible radiation of current form of alterations of drugs used in the primary health care.
( three ) The bing system of associating monetary values of locally produced drugs with costs of natural and packing stuffs and that of imported finished drugs with
landed cost should be revised for rational repair of Maximum Retail Prices ( MRP ) of drugs.
8. Quality confidence of drugs and pharmaceuticals
One of the most of import aims of the NDP is to do good quality drugs available at low-cost monetary values. In order to accomplish this aim. quality edifice in a drug at the fabrication phase by in procedure quality control and quality maintaining in the drug in theodolite and storage should be ensured by proving it at different phases before it reaches the terminal –users.
( I ) Each pharmaceutical company should hold a quality control and quality confidence system. which would supervise the full procedure signifier the acquisition of natural stuff to its transition into a finished merchandise.
( two ) Each Manufacturer should hold a dedicated squad of professionals for equal merchandise and procedure design and statistical control of the procedure through in- procedure and end- merchandise testing.
( three ) There should be documented Standard Operating Procedure ( SOP ) based on WHO recommended cGMP guidelines for industry of each merchandise every bit good as for each fabricating unit procedure.
( four ) All the unit procedure should be sporadically validated to guarantee right terminal –results. The proof consequences should be decently documented.
( V ) Qualified professionals related to pharmaceutical scientific disciplines should be employed in all the relevant sections. related to quality control and quality confidence. of a fabrication works following the guidelines of WHO in order to guarantee production of good quality drugs.
( six ) Quality of marketed drugs should be ensured by frequent post-market surveillance by the Drug Inspectors and proving random samples of the marketed drugs in the Quality Control laboratories.
( seven ) In add-on to the QC research labs of the companies there should be one
Cardinal Drug Testing/ Quality Control Laboratory and a figure of Regional Drug Testing/ Quality Control Laboratories under the Directorate of Drug Administration with separate units for unani. ayurvedic. herbal and homeopathic-biochemical drugs. manned by proficient experts of the several subjects.
9. Manpower of the fabricating units
( I ) All fabricating units should be staffed with equal figure of Professionals related to Pharmaceutical scientific disciplines in conformity with WHO guidelines in order to bring forth good quality. safe and effectual drugs and pharmaceutical.
However. the unani. ayurvedic. herbal and homeopathic-biochemical drug fabricating units should be staffed with equal figure of Qualified individuals of the several subjects and. where necessary. druggists. chemists/ biochemists. and phytologists.
( two ) Persons with relevant makings should be employed in the assorted sections of the fabricating units following the guidelines of WHO and purely following the relevant Torahs of the state.
( three ) Adequate figure of other back uping trained and skilled