The Rx Radar

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Major General Md. Mustafizur Rahman is the Director General of the Directorate General of Drug Administration (DGDA). General Rahman had his MBBS from Rangpur Medical College under Rajshahi University, Bangladesh in 1987 and MPH from Dhaka University in 2004. He joined the Bangladesh army in 1987 as a Doctor. His has previously worked as the Director of Dhaka Medical College Hospital and served as an Army Medical Doctor in OKP-5 in Kuwait from 1999 to 2002.

Once upon a time, there was a dearth of medicine in Bangladesh. However, now the local companies are controlling the market share. What is the story behind this?
After our liberation, local companies enjoyed only 30% of total market share, and Bangladesh was a drug import-dependent country. After implementations of The Drug (control) Ordinance 1982, the scenario changed dramatically, and currently, local companies possess about 98% of the market share. Only 2% drug are imported which are high-tech based products. Now, Bangladesh is exporting medicine to 123 countries around the world.

What is the process of getting permission for new drugs in the market?
When any company applies for the registration of new medicines for local manufacturing or import purposes, the application is screened by the officials of DGDA first. Later the application is evaluated by a technical sub-committee of the Drug Control Committee. The recommendation of the technical sub-committee is then placed before the DCC meeting. The technical sub-committee and Drug Control Committee comprises of different experts of various disciplines.
For locally manufactured drugs, the technical sub-committee evaluates them on the basis of whether the proposed product has already been approved by the USFDA (United States Food and Drug Administration)/UK-MHRA (Medicines and Healthcare Products Regulatory Agency) or included in the British National Formulary (BNF). For the imported drugs, the application is evaluated on the basis of registration and free sale status in advance in seven countries. For veterinary products, the status of registration and free sale certification in listed 24 countries is considered. After the recommendation from Drug Control Committee, the Licensing Authority of Drugs registers the new product following all other formalities.

There are adulterated drugs as well as expired medicines in the market; what are your ways and means to contain this problem?
The officers of DGDA carry out raids in different drug markets in the country on a regular basis. Mobile courts are also active against the drug law violators and take punitive actions when necessary. Sometimes joint programs with other law enforcing agencies such as Magistrate, Police, RAB and DGDA officials are launched. As a result adulterated, spurious and sub-standard drugs are being expelled from the market. Due to the post-marketing surveillance activities of the Drug Administration, these types of medications have been reduced significantly. If any expired drugs are identified in any pharmacy, they are seized as per the law and action is taken, accordingly.

How are you checking the quality of medicines?
Post marketing samples of drugs are collected on a random basis from the market, company premises and depots. These samples are being tested in Government laboratories to determine their quality. After the examination, the government analyst issues the certificate of analysis. If any product is proven to be substandard by the tests or trials, DGDA instructs the manufacturer to withdraw the products immediately from the market after which they must publish an advertisement in the three national dailies. DGDA also suspends or cancels the product’s registration and files a case against the company for producing substandard products. We have two Government Drug Testing Laboratories in the country, National Control Laboratory (NCL) located in Dhaka and Central Drug Testing Laboratory (CDTL), based in Chittagong. The NCL has been upgraded and modernized with very sophisticated equipment.

What are the main challenges for this sector?
Only fifty-seven companies are producing 80 varieties of raw materials, pellets, and capsules in the country. This means the pharmaceutical industry has to be reliant on imported raw materials which requires substantial investments. However, the positive news is that the government has taken initiatives to establish an API park in Gozaria, Munshiganj. In order to export internationally bioequivalent drugs, study report of the drug must be conducted as per the requirements of the different countries. This has to be done in another country which means the expenditure of foreign currency. The very optimistic message is that a GCP (Good Clinical Practice) Guideline has been approved by Ministry of Health and Family Welfare recently. Three Contract Research Organizations (CRO) has been approved, and the clinical trials have started in the country. A medical device registration guideline has also been prepared and approved by the Ministry of Health and Family Welfare. Registration of local manufactured and imported medical devices are given according to the guideline.

What is the future of this industry?
The industry has progressed well over the last three decades, and the country is nearly self-sufficient in pharmaceuticals with 98% of its demand being met by domestic manufacturers. Consistently posting double-digit growth over the previous years, the pharmaceutical industry remains one of the most technologically advanced sectors in the country, employing probably the highest number of white collar professionals. The companies in Bangladesh are now manufacturing almost drugs from all therapeutic categories namely antibiotics, anti-ulcerants, antihypertensives, analgesics, steroids, hormones, antihistamines, anti-diabetics, anti-cancers, anti-asthmas, vaccines, biologics and so on. Besides conventional products, leading companies have a range of specialized high-tech products which require sophisticated technical skill. These include injectable, metered dose inhalers, dry powder inhalers, prefilled syringes, lyophilized drugs, sterile ophthalmic, oral thin films, etc.
Bangladeshi medicines are being exported to 123 countries around the world, and the leading players are already supplying to the regulated markets of USA, Europe, and Australia which are known for their strict regulations and standards. Given its export potential, the pharma sector has been declared as a thrust sector in Bangladesh with an aim to diversify the country’s export portfolio. Leading pharma companies have already secured accreditations from major drug regulatory agencies like US FDA, UKMHRA, TGA, ANVISA, GCC, Health Canada, etc. Also, the Bangladesh government has taken a lot of initiatives for increasing the export of the Pharmaceuticals Products.

What is the process for FDA approval?
The Company has to apply to US-FDA. The experts visit the companies and evaluate their products and procedures meticulously. Many requirements are set by the experts, all of which have to be fulfilled. After meeting the requirements, the company receives approval for their products.

How does the DGDA aim to promote good marketing practices?
The DGDA vision is “Quality and Safe Medicine, Healthy Nation”. The DGDA’s mission is to ensure that the people have easy access to useful, effective, safe and good quality medicines, vaccines and medical devices at affordable prices through a system of regulation and control. Good marketing practices of drugs should be followed by all manufacturing and importing companies, giving the highest priority to public health. Unethical and illegal practices should be avoided.
A code of pharmaceutical marketing practices has been prepared with the initiative of the Drug Administration. Every manufacturer and importer should follow it for the betterment of the patients and to maintain the discipline of pharmaceutical marketing.

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