The pharmaceutical industry in South India have unanimously decided to oppose and appeal for further timeframe against the Kerala drug control administration's decision to mandate cGMP certification and valid drug manufacturing license for small scale pharmaceutical companies operating in the state through the Propaganda Cum Distribution (PCD) channel. Further, the industry associations are planning to bring the issue to the notice of the Drugs Controller General of India (DCGI).

A team of office bearers of the Indian Drug Manufacturers Association (IDMA) South Zone and the Federation of South Indian Pharmaceutical Manufacturers Association (FOSIPMA) would meet the Kerala Drugs Controller within a few weeks and would appeal for more time, at least by March 2006, to submit the documents, sources told Pharmabiz. The IDMA is also planning to send a delegation to meet the DCGI to secure enough time for the manufacturers to get the cGMP certificate.

The decision of Kerala DCA is decisive to the SSI drug manufacturers of neighbouring states, as these states account for a substantial share of drugs distributed in Kerala, noted S V Veeraamani, vice chairman of IDMA. Most of the SSI manufacturers are still in the process of developing their facilities according to the new GMP norms. The process will take more time, as the SSI manufacturers are facing severe financial crunch, mainly because of the MRP based excise burden. Even after completion of works, it takes many months to issue the certificate, noted Veeraamani, also the chairman of the SSI sub-committee of IDMA. The FOSIPMA is also seeking an appointment with the Kerala Drug Controller to plea for more time, said sources.

Meanwhile, the Confederation of Indian Pharmaceutical Industry (CIPI) has written a letter to the Kerala DCA asking for extension of deadline to submit cGMP certificate, upto March 2006. The organization hopes that the Kerala Drug Controller will reconsider the decision. According to T S Jaisankar, chairman, CIPI, about 20 per cent of the total drug distribution in Kerala is from companies of neighbouring states, while about 75 to 78 per cent are from MNC's and one or two per cent from the state itself.

Pharmaceutical companies located at Gujarat, Karnataka, Haryana and Rajasthan mainly meet the Kerala Government's drug requirements. The DCA would discuss the issue with the state health department, said A. Abdul Shukkoor, Drugs Controller of Kerala. He said that the DCA would remain stern in its decision to implement the rule on PCD players.

As Pharmabiz reported earlier, the DCA instructed the drug inspectors, in a letter dated 2nd August, to identify the first distributors of general drug items and PCD drugs in the state market and direct them to produce valid cGMP manufacturing certificate and relevant manufacturing licenses before 1st of October before the DCA. The companies failing to present the documents would be banned from selling in the state and would be allowed to resume distribution after subsequent production of documents, said the letter.