Chronicle Pharmabiz, in its last issue, published a report revealing that 200 nimesulide formulations marketed in the country are without the approval of Drug Controller General of India. Out of these 200 products, 70 are nimesulide suspensions and the remaining 130 are fixed dose combinations of nimesulide with a number of other drugs. Combinations of nimesulide and paracetamol, numbering 50, are the largest segment in this group. Combinations of nimesulide and two muscle relaxants namely tizanidine and serratiopeptidase with as many as 52 brands are the other two major combination groups. Top selling brands in all the three categories are being marketed by major pharmaceutical companies in the country. What is astonishing here is that so many irrational combinations of nimesulide are being marketed in the country at a time the very safety of this drug is under a cloud. In an affidavit submitted to the Delhi High Court recently, DCGI has stated that most of these 200 formulations are approved by state drug control authorities. It is not that this information is a bolt from the blue. The pharma companies who indulge in this unethical practice are well aware of this number and what that means to them. The medical practitioners who actively promote these products also know this and their harmful effects on the patients. But, the fact that DCGI had to helplessly admit this to a higher court in the country points to a grave truth: There is no accountability in the drug administration in this country.
The provisions of Drugs and Cosmetics Act do not allow state drug authorities to grant manufacturing licences for fixed dose combinations of new drugs. This is on the premise that any combination of one or more drugs will act differently on patients and therefore any combination has to be treated as a new drug. And approval for marketing a new drug in India has to be granted by only DCGI after completion of necessary clinical procedures. All state drug authorities are expected to know this simple rule. But even well informed heads of certain state drug authorities violate this basic rule by taking a stand that the same combination is allowed by another state drug administration in the country. No chiefs of any state drug authorities have ever cared to take a position that they will not grant manufacturing licenses for a combination without the approval of DCGI even if some other state approved such a combination. At the same time, by stating that most of these combinations of nimesulide are approved by state drug authorities, office of the DCGI cannot clear itself from its responsibility for the existence of such a huge number of irrational and therefore harmful products in the market. Irrational combinations of nimesulide is only a tip of the iceberg. There are thousands of combinations of various other essential drugs floating in the market, which are also wrongly approved by state authorities. And there is no hope that flow of such harmful combinations into the market will be under check in future under the existing system of drug administration. This calls for establishment of a highly centralized drug control machinery with stringent coordination and adequate infrastructure in this country.