With less than a week for the deadline of December 31, 2003 for complying with the Schedule M norms, the small drug units in the country have begun frantic efforts to get an extension, while the government is trying to assess a last-minute comparative study on the norms.
Informed sources told Pharmabiz.com that Sushma Swaraj, union minister for Health and Family Welfare, has asked for a detailed report from the Drug Controller General of India (DCGI) two days ago on the changes that have been incorporated in the Schedule M notification, in comparison to the norms announced in 1987. Besides, she has also asked for details on the cost factor involving investment on the part of SSIs, in a slide presentation format with statistics. The DCGI was likely to submit his report today, and the minister may take a decision within the next few days, said sources.
Meanwhile, the SSI units are trying their last lap of pressurizing efforts to see them get an extension. While the SSI leaders are camping in New Delhi to discuss the matter with the minister, mails and faxes detailing the plight of SSIs are pouring in from different parts of the country into the minister’s Health and Family Welfare office and residence in Delhi. “At least 20 to 30 mails and faxes have been sent from each of the states in the last two days. The minister should know our predicament,” said a top level SSI association office bearer.
The sources said that the government was also trying to assess their complaints on inadequate time for implementing the Schedule M norms. “In the case of units in West, WHO had incorporated changes in the WHO-GMP guidelines from time to time, say one or two every year, and the units had almost 14 years to incorporate the changes one by one, year after year. Therefore, the transition to WHO GMP guidelines was smooth and easy for the SSI units. In India, we had the guidelines in 1987 in accordance to the then existing norms of WHO. The proposed GMP norms demand our units to incorporate all these changes in a very short time. We have brought this to the notice of the minister” said a source.
Sources said the timeframe for extension was still a debatable issue within the top-level authorities, though it was more or less confirmed that the extension would come before December 31 2003. While some of the top officials were for only one-year extension, some favour two years as Pharmabiz had reported earlier, said sources.