The small-scale pharmaceutical manufacturers in the country, already in doldrums due to the Schedule-M norms that forced them to invest many crores of rupees on infrastructure, fear that the proposed move to introduce Good Laboratory Practices (GLP) norms will hasten closure of numerous SSI units.

Sources said as per the proposed draft notification announced two months ago, the units will have to invest a minimum of Rs 1 crore for complying with the GLP norms, in addition to the investment already made to comply with Schedule-M provisions. The amendment calls for investment on infrastructure and machinery for laboratories including in-house facilities. If the draft gets passed without changes, SSIs, which have just survived through the upgradation process of Schedule-M, would be forced to make additional investments.

The Confederation of Indian Pharmaceutical Industry (CIPI), the apex body of the manufacturers of drugs and pharmaceuticals in small-scale sector, has demanded the government to constitute a committee with adequate representation from the sector to review the move.

In a letter to the Central Ministry of Health and Family Welfare, the Confederation, an apex grouping various state level SSI pharma associations, pointed out that if the draft rules are implemented in its present form, a large number of small-scale units would be forced to close down their manufacturing facilities. Further, there is lack of clarity in the notification.

"The government should first make it sure that the labs under their direct scrutiny and the commercial labs, which plays a major role in the laboratory activities of the industry, are having the same standards. It is not fair if the authority is only targeting the industry. There is lack of clarity in such things," T S Jaishankar, chairman of CIPI told Pharmabiz. He added that lack of trained manpower in the country to handle the laboratories would complicate the upgradation process or setting up of GLP laboratories, as per the standards mentioned.

The draft amendment of Drugs and Cosmetics Act 1945, in this regard, suggest inclusion of Schedule-L-1 in Rule 74, 78 and 150-E to make the GLP mandatory for approval of licence for pharma companies.