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DCGI had then ordered an investigation to assess the safety profile of the drug in the Indian

It is after several years of debate, the Drug Controller General of India decided to ban the manufacture and sale of 4 controversial drugs namely nimesulide suspension, cisapride, PPA and human placenta extracts in the country in February last. The notification to this effect was issued on February 10 after Drug Technical Advisory Board recommended their withdrawal from the market. The DTAB has been examining the safety profiles of the drugs for some years and advised their recall from the market as their adverse effects outweigh the benefits. 

These drugs have been already banned by many developed countries over ten years ago. In India, the dangerous side effects of nimesulide was brought to the notice of the DCGI first time by the Ahmedabad based Consumer Education and Research Centre in April 2000. DCGI had then ordered an investigation to assess the safety profile of the drug in the Indian context and nothing further happened and the drug remained in the market since then. Obviously there has been pressure on the office of DCGI to not to issue the ban order as some of the drug companies stand to lose several crores of rupees of business. However due to persistent pressure from independent medical experts and consumer groups, DCGI came out with the notification.

The decision for withdrawal of four drugs by the DCGI was well received by the pharma industry associations and there has been no serious objections to the order as it is in larger public interest. Subsequently, the state drug controllers have started taking the follow up actions to enforce the order. 

In fact, Andhra Pradesh and Gujarat drug control departments have already issued stop sale orders of these four drugs in their states within a few days of the DCGI’s directive. The only demand from some of the associations representing small scale units was to postpone the ban of sale these products till the expiry of stocks in the trade channels. That is a reasonable request and state drug controllers have already agreed to consider this demand. What is disturbing the DCGI and medical experts now is the stay granted by the Madras High Court against the government ban order last week on a petition filed by a leading pharmaceutical company. 

The Court should have duly considered the entire background behind such a government order before stalling it. Any continuation of marketing drugs with major ADRs could be highly dangerous to the millions of patients who are taking them. And when the country’s most authoritative body recommends a ban on the basis of technical findings, no pharmaceutical company has the moral authority to move court against such a step. Now having issued the order and state governments started acting on it, the DCGI has to uphold the order in the public interest. DCGI’s decision to move the Supreme Court for vacating the stay is thus just humanitarian and fully justified.


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