Large quantities of inferior quality drugs are entering the country despite the system of centrally controlled import registration in force since April 2003. Such imports inferior products are, in fact, adding to the menace of spurious drugs.

Outdated testing specification in the Indian Pharmacopoeia (IP) is stated to be one of the major reasons for such undesirable import of inferior quality drugs. With the number of such cases are on the rise, IP experts feel that only a drastic revision of manufacturing specifications in the IP can only bring some control to this menace.

"Our IP specifications are 8 to 10 years old. It is this legal loophole that enables the importers to dump less quality drugs into the country," Dr P R Pabrai, member IP committee said. He pointed out that the existing IP Committee never had the resources or infrastructure validate the latest technologies introduced by the pharmaceutical industry. "Specifications of several pharmaceutical products need upward revision because the industry has been able to upgrade the technology of manufacture. They are in fact waiting for the IP committee to validate their new technologies and come out with revised monographs. Unfortunately, there are no resources available for the purpose," Dr Pabrai bemoans.

"Today we are not in a position to come out even with an IP addendum (on time). This happens due to several administrative problems," he added. Dr Pabrai hoped that the establishment of autonomous IP Commission would change the whole scenario and the country would be in a position to come out with validation at international levels. Interestingly, the changes in validation might trouble the more conventional SSI, medium scale drug-manufacturing sector. According to Dr Pabrai, the small companies may not be able to go for expensive validation / manufacturing technologies. 'The existing system therefore should continue even while newer methods are introduced unless these procedures are against the interests of the consumer," he concluded.