The small-scale drug manufacturing sector in the country is divided over their approach towards Schedule M compliance by year end. Even as the Confederation of Indian Pharmaceuticals Industries (CIPI), a grouping of state associations of SSI drug makers is lobbying with the Centre to get the new Schedule M requirements made mandatory only for companies that came up after 2001, CIPI constituents like M P Small Scale Drug Manufacturers Association (MPSSDMA) fear that any such move may result against the interest of earlier licensed SSI units.

They point out that acceptance of such a proposal would lead to an automatic exclusion of SSIs from Institutional & other businesses. With DCGI taking a step to ensure that Indian GMP (as per revised Schedule M) is becoming the basic criterion for participating in domestic tenders, SSIs should comply with Schedule M norms to be in the race, they opine.

According to Jagmohan Rai Agarawal, chairman, MPSSDMA, the need of the hour is to subject the entire provisions of revised Schedule M to micro- analysis with active participation of SSI and come out with a revision that is reasonably acceptable to SSI.

He felt that once the Schedule M issue is sorted out, the drug industry organizations should see the scrapping of turnover barriers posed by the procurement agencies. "Various institutional tenders stipulate clause of minimum annual turnover, ranging from Rs 10 lakhs to Rs 200 lakhs, at present. This qualifying precondition has no link between quality and quantity and just help the MNCs and Indian pharma majors to create a monopoly in institutional business," he said.

Explaining what he termed as double standards by big pharma, Agarawal said that the "companies of high turnover quote very competitive prices when there is no turnover stipulation and they are in direct race with SSI. But the same companies quote higher prices wherever they have an assured business, by way of turnover clause." Taking note of the recent central (SSI Ministry) directive to Karnataka (vide letter dt. 23rd June 04), to delete the clause of Rs 1 crore annual turn over from one of its tenders, he said that there should be no reservation for any class of Industry not even based on state policies.

"Everyone including pharma SSI should be allowed a "level playing field" without compromising on quality," he added.

According to him, the interpretation of the standards of a drug as defined in the second schedule of Drugs and Cosmetics Act/Rules differs widely from state to state and analyst to analyst. This has resulted in a great deal of misuse, which is directly harming drug SSIs, he said.

"More than 95 per cent of prosecution cases are baseless, unfounded, unlawful, has no malafide on the part of accused (trade/Industry) and are simply causing harassment to regulatory as well as to accused and/are not likely to result in conviction finally. Even if some cases result in conviction the same may be due to improper presentation of the case(s) due to lack of knowledge of legal provisions and to some extent prejudice mind of judiciary," he explained.

MPSSDMA wanted this matter of quality, provisions of Act/Rules, Penal both departmental and legal, etc to be subjected to National debate. "Let the government both at centre and state levels, constitute a high- power committee, with participation of SSI to scrutinize all pending legal cases and after consideration of arguments and record available, may recommend whether to continue with the case(s) or withdraw the same," he suggested.