Updated drug policy okayed by cabinet

The cabinet yesterday approved the draft of revised and integrated drug policy, first of its kind in Bangladesh, to make sure pharmaceutical products meet international standards and substandard, fake and adulterated drugs are checked.

As it got the go-ahead, drug manufacturers have hailed the policy that will also regulate marketing, pricing and selling of essential drugs in the local market.

The National Drug Policy 2016 will replace the existing one framed in 2005, Cabinet Secretary M Shafiul Alam told reporters after the cabinet approved its draft at a meeting at the secretariat with Prime Minister Sheikh Hasina in the chair.

It has an extended list of essential drugs -- from 205 to 285 -- and provides for restrictions on sales of over-the-counter medicines, said Prof ABM Faroque, convenor of the 12-member sub-committee that prepared the draft.

According to the policy, no one can buy drugs without prescriptions from physicians, except 39 allopathic, 23 ayurvedic and 48 unani medicines. This is very important as indiscriminate use of medicines, especially antibiotics, is harmful for public health.

“This is the first time a drug policy has brought allopathic, ayurvedic, unani and homeopathic medicines under one umbrella,” said Faroque, professor of pharmaceutical technology at Dhaka University.

Such integrated drug policy is the first of its kind in Southeast and South Asia, he added.  

Pharmaceutical manufacturers said the updated policy was a longstanding demand from their side. They want its immediate implementation for further growth of the pharmaceutical sector, which is, according to them, the second largest in terms of export.

Bangladesh exports pharmaceutical products of nearly Tk 2,500 crore a year while the local market value is around Tk 15,000 crore, according to the manufacturers. 

Briefing reporters on the policy, the cabinet secretary said Bangladeshi medicines are now being exported to some 122 countries and so it is very crucial to ensure standards of the drugs.

The policy also provides for availability of effective, safe and standard drugs, rational and safe use of drugs, registration of drugs, registration for importing drugs as well as manufacturing drugs and its raw materials.

There are proposals as well for the formation of a national drug regulatory authority, advertisement control, publicity of drugs and joint initiatives for research and development.

The revised policy makes storage or display of drugs with the expiry dates changed or distorted a punishable offence. Legal steps would be taken against people for charging customers additional prices. 

Considering public interests, Cabinet Secretary Shafiul Alam said, pricing rules of medicines would regularly be updated while the price list would be updated once a year and made available online.

The policy incorporates guidelines of the Good Manufacturing Practices (GMP), Alam said, adding that many local drug manufacturing companies had already received the GMP certification.

He added that the new policy addressed the demands of the WHO, Food and Drug Administration of the USA and the UK as some companies like Beximco, Square, and Incepta had received certificates from the WHO already.

“It is a very good initiative of the government. It will help discipline fake and adulterated drug manufacturers. Had it been done earlier, it would have been better for this growing sector,” said Ahmed Kamrul Alam, general manager [marketing] of Square Pharmaceutical Company.

The policy will overall have a positive impact on drug manufacturers, he added.    

Hailing the policy, Mizanur Rahman Sinha, managing director of Acme Laboratories Ltd, said both the local and international markets of pharmaceutical products have been expanding every year. The policy will ensure compliance with international standards, thus facilitating export of Bangladesh medicines to key international markets like the United States that only Beximco had so far penetrated.

Once the revised policy is implementation, there will be little scope for sub-standard and adulterated drug manufacturers, he added.