Even as the small and medium scale drug manufacturers continue their complaints against the Good Manufacturing Practices (GMP) norms under revised Schedule M of Drugs and Cosmetic Rules, the ones who are willing to comply with the norms are alleging that the central drug enforcement agency is attempting to enforce Schedule (M)-Plus requirements through its inspection check list.

The unofficial check list, prepared by the central authorities to be circulated among state drug regulatory officials for uniform implementation of Schedule M, is creating unnecessary hurdles, SME drug makers complain.

The manufacturers feel that several queries mentioned in the check list are not concerning the quality aspects of the drug manufacturing process. "Instead of inspecting our ability to manufacture quality drugs, this checklist seeks to make us respond to redundant questions. It can only lead to increase in official harassment," they fear.

The SMEs feel that the queries that lead to disclosure of contract agreements with manufacturing firms have nothing to do with the GMP norms. "The check list seeks to understand whether there is a written valid contract covering the manufacturing and/or analysis. It wants to know whether contract describes the handling of starting material, intermediate and bulk product and finished products, if they are rejected. We cannot understand why these matters are linked to Schedule M," they say.

The check list that asks 'whether personnel are trained on induction, details of ongoing and new refresher training programmes, periodic medical examination reports of staff, number of uniform sets or protective clothing…' are providing officials to interpret the situation in their own way, they add.

According to them there are about 160 points that should be considered by the inspector visiting a drug manufacturing site. The questions range from general to highly technical. The small drug units feel that there is no need for them to be so high-tech to produce quality drugs. "The focus of GMP has shifted from quality consideration to capital investment considerations. It's the amount of capital investment you make that qualifies your unit as a good one today. This system is basically flawed. The SSIs of the country have been proving for decades now that quality medicines can be produced from plants that are set up with moderate investments. The revised GMP norms are a challenge to our business and not really about quality and safety of drugs", they complain.

Meanwhile, senior drug regulatory officials downplayed the importance of the issue. Acknowledging the presence of a check list, they said that they were not sure about the extent of its usage as it was only of advisory nature. "We have prepared a model checklist. That is only meant to aid the drug official. The inspections are conducted as per the new GMP requirements and not the check list. We are not even sure about the states that are following the check list. It should be a real concern for the industry," they informed.