DTAB forms panel to review SSI’s plea on Schedule M

Jayashree Padmini - New Delhi

The Drug Technical Advisory Board (DTAB) has formed a Review Committee to look into the demands made by the Small-Scale Industry players with regard to the implementation of Schedule M.

The committee, comprising four members including industry representatives and representatives from Drug Control office, will submit its recommendations to the DTAB in six weeks, it is learnt.

The government had notified the amendments to Schedule M last year on good manufacturing practices and requirements on premises, plant and equipment for pharmaceutical products. As per the amendment, the drug manufacturers in the country are required to upgrade their facilities to match with the stipulated standards by December 31, 2003.

In view of the inability of the SSI units to upgrade the facilities to the required standards, the SSI manufacturers association and Indian Drug Manufacturers’ Association have been seeking a five-year extension of the time limit.

The SSI representatives, in a memorandum, have also sought financial assistance to upgrade manufacturing facilities apart from extension of time, it is learnt.

Sources said the regulatory decision is that Schedule M implementation will not be delayed. However, political compulsions may change the position, at least for the SSI segment.

The Review Committee will start the deliberations shortly and will consult experts as well as industry representatives while formulating the suggestions. They will also debate in detail the suggestions put forward by the SSI sector in this regard and study the practical difficulties involved in effecting GMP as per the Schedule M amendment.

Rough estimates put the cost of upgradation to GMP standards at Rs 5-10 lakh as the units need to put in place basic facilities such as air handling system and water purification system and employ a microbiologist.

A major cluster of the SSI pharma units is concentrated in the northern belt, say, Indore, Rajasthan, Haryana, Punjab, Uttar Pradesh and Himachal Pradesh. Of the 10,000-odd units, about 80 per cent would have to down shutters if the government goes ahead with the deadline of January 1, 2004, say SSI representatives.

According to the statistics available with IDMA and OPPI, there are between 17,000 and 23,000 small units in the pharma sector that would be hit by the new norms.

Although there is a concern over the likely phasing out of many a small- scale player, the Schedule M amendments, once implemented, would bring in dramatic changes and take the industry closer to WHO GMP.