The Ministry of Small Scale Industries is likely to offer its support to the small-scale drug-manufacturing sector in the latter's attempt to bring about further relaxation of Schedule M norms.
The intervention of the SSI ministry has become necessary in the wake of increasing complaints reaching the office of the Development Commissioner (SSI) regarding the genuine difficulties being faced by the SSI drug sector when it comes to Schedule M compliance.
Responding to the SSI plea, the office of the Development Commissioner (SSI) has asked the associations representing drug SSI units to pinpoint the clauses that are really troublesome for them. The Development Commissioner wants the SSIs to go through GMP norm point by point with a view to list out clauses that are difficult to comply with. The SSI ministry may request the ministry of health and family welfare to look into these clauses for possible modification. The SSI ministry is to target the specific, genuine issues troubling the SSI sector and present the case before the health ministry.
The Development Commissioner wanted the industry to submit their detailed representation / complaints by January 20, 2005. Stating that the Schedule M norms are based on WHO guidelines and are in the interest of the industry, the ministry wanted the SSI sector to realise that the compliance would help them to ensure the quality of their products. This would result in better marketing prospects in the domestic and international markets, the ministry pointed out.
The ministry has also made it clear that repeated extensions of deadline for compliance will neither serve any purpose nor may be possible to secure again. "The representations received so far indicates a hesitation on the part of the units in the SSI sector to adopt these norms and there may be some genuine reasons for the same", the ministry has felt. The office of the Development Commissioner would attempt to identify those reasons and sort it out in the interest of the SSI sector.
The SSI ministry's gesture couldn't have come at a more appropriate time as the Confederation of Indian Pharmaceutical Industries (CIPI) had decided to make use of the six-months extension period granted by the health ministry to comply with the Schedule M norms to lobby for further relaxation of the GMP norms for the existing SSI drug units.