Bringing discipline in drug industry


Nilratan Halder | Published: June 17, 2016 00:00:00 | Updated: February 01, 2018 00:00:00


That the government has ordered a halt to operation by 20 pharmaceutical companies is not for nothing. Anarchy has long been reigning supreme in the drug industry. A number of drug manufacturers have been abusing the licences they obtained in a drug administrative regime not armed with a national drug policy. So the authorities had to revoke the licences of 11 drug companies and ordered nine others to stop their production. Licences of these nine companies could not be cancelled because they had got a stay order on suspension of their licences to continue running them. A review petition filed by a couple of such companies has been dismissed by the Appellate Division of the Supreme Court. So the drug administration ordered them not to go for further production. Besides, 14 other companies have been barred from producing all kinds of antibiotics. 
The action has rightly been taken for the erring drug companies' failure to comply with the good manufacturing practices (GMP) set by the World Health Organisation (WHO). But it did not happen straightway. An expert committee formed by the parliamentary standing committee on the health ministry in 2014, came up with their findings in April last. The committee pointed out the lacking on the part of the 34 companies on various counts. The drugs and antibiotics manufactured by these drug companies were found substandard. 
How long it would have taken to swing into action against the pharmaceutical companies had the High Court not issued the rule on a writ petition moved by the Human Rights and Peace for Bangladesh, a rights organisation, will never be known. What will continue to irk people, though, is the failure to compel the drug companies to call back the substandard medicines and antibiotics from the market. However, the drug authority has issued a warning against marketing of drugs produced after June 07 last, the day the HC delivered the verdict, by the blacklisted companies. 
This is rather curious. If the drug companies have been ordered to stop manufacturing drugs, how does the question of their further production arise? Unless they appeal for review in the Appellate Division, the doors of the factories have, of necessity, to be sealed. Further manufacture of drugs is possible only if they have underground facilities for clandestine production of drugs. 
In 2014, the formulation of a forward-looking national drug policy in place of the 1982 protectionist one suffered a reversal only because of naivety on the part of all who were involved with the process. What is the current state of that draft drug policy? A circle in the drug administration deliberately left out a member on the policy-formulation committee from the exercise. When the national drug policy was submitted to the health ministry, the bypassed member representing the pharmaceutical society took the matter to the court. Both the lower court and the HC gave verdict in his favour. Thus the draft national drug policy came to a dead end. 
There is an impression that the chaos in the pharmaceutical industry is allowed to continue deliberately in order to reap unearned benefits from it. Until or unless sensational or tragic news hits it, the administration hardly makes any move to clear the mess. When the media come up with news about spurious medicine or other drug scams like that of paracetamol involving the tragic deaths of children, the drug authorities become active. 
Drug manufacturers have taken full advantage of the disorder in the sector. Ever since the attempt made by the health ministry to bring discipline in the industry, drug market has been jittery. Prices of locally manufactured drugs have gone up several times in the absence of competition from imported varieties. It is a pity that prices of life-saving drugs are raised like commodities in the absence of a national policy or guidelines. Similarly, food supplements for infants too are randomly sold without taking into account the adverse impacts on their health. 
There is no alternative to streamlining the drug industry of the country. Against the malpractices by some notorious pharmaceutical companies, some in the business have maintained a world class standard for drug manufacture. Quite a few of those now export drugs with reputation not just to developing countries but to developed countries as well. The potential of the drug business abroad has been exploited on a very limited scale. Experts in the sector are of the opinion that the country's current annual earning of $ 25 million can be increased 10 folds, if not more, by 2020 provided that the process of export by the pharmaceutical companies is facilitated. There are a number of impediments on the way to expanding export of drugs. If those are removed, the volume of export will automatically go up. 
The reality is that the health sector has been neglected for long and the overall picture is dismal. It is because of this, the health minister has to come up with a statement that no compromise would be made on the quality of medical education. He makes the declaration after ordering closure of three medical colleges. This spirit should be taken to healthcare facilities, diagnostic centres, private practice by physicians and other areas related to the health sector in order to maximise the impact of the good work. All this can be accomplished under a comprehensive national health policy. But first a national drug policy has to be readied for bringing discipline in the pharmaceutical industry.
nilratanhalder2000@yahoo.com

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