Having a person for liaisoning with various government offices in Delhi is a practice the large pharmaceutical companies have been following for some time. Today, even medium and small pharma companies also have liasoning representatives in the capital with increasing delays in getting various regulatory approvals from government offices particularly from the offices of the Central Drugs Standard Control Organisation. No doubt, the workload in these offices has increased over the years with no matching increase in the number of officers and supporting staff. The main objective of keeping these liaisoning men, therefore, is to push the files by all means and get the clearances as fast as possible. It is a known fact that the pace of work in all government offices is usually slow. With increasing number of applications from the pharmaceutical companies, the work in these offices has become extremely slow. And even liaison men are finding difficult to get approvals with their usual tactics now. This matter has been reported by Chronicle Pharmabiz in the issue dated July 22, 2004. In the report, companies have bitterly complained that working of CDCSO is dismal and it has no systematic approach to processing and disposing off various applications relating new drug approvals, export related matters,etc. The companies have also stated that they are facing the prospects of losing foreign contracts for formulation exports, bioequivalence studies and clinical trials in the process.

The recent detection of a racket involving forging of new drug approval letters is an offshoot of this chaotic situation existing in CDCSO offices. The detection was made by S P Adeshara, the commissioner of Food and Drug Control Administration of Gujarat last week with assistance from Drug Control General of India. The commissioner found that out of the 18 new drug approvals supposedly issued by the DCGI to 7 Gujarat based drug companies, 17 were bogus. FDCA has promptly cancelled all manufacturing licenses issued by it on the basis of these forged DCGI approvals. Gujarat FDCA should also order a recall of all products under these licenses within a time frame. Now, a bigger question to be addressed is how many such fake approvals are not detected and the number of manufacturing licenses issued on the basis of such fake approvals by other state drug controllers. That calls for a close scrutiny of all drug-manufacturing licenses issued by state drug controllers in the recent past. Such an exercise is extremely significant and urgent in the interests of public safety. Detection of these fake approvals is also a warning to the office of DCGI that someone from this office is possibly helping such anti social elements. For the healthy growth of an industry like pharmaceuticals, existence of a strong central administrative machinery with adequate number of qualified staff is critical. And that is possible only if the Union health ministry takes this industry seriously.