The newly formed SME Pharma Industries Confederation (SPIC), an association of thousands of small pharma companies, has urged Prime Minister Dr Manmohan Singh to keep the implementation of Schedule M in abeyance till the Najma Heptullah Parliamentary Committee comes out with its recommendations.
In a letter addressed to the Prime Minister, the SPIC asked the Central government to save the SSI pharma units in the country by keeping the implementation of Schedule M on hold. The Heptulla Committee is expected to submit its final report to the Prime Minister soon.
The parliamentary committee headed by Dr Heptulla was constituted to study the impact of the implementation of revised Schedule M in the pharmaceutical industry in the country. The committee, which had several sittings in different zones of the country for collecting data to finalise the report, was to submit its report during the last monsoon session of Parliament. But after several meetings with officials and industry association representatives, the committee failed to come to any conclusion so far. The committee had recently visited Mumbai to hold another round of discussions with the officials and the industry.
The SPIC letter said that when Schedule M of Drugs Act was implemented in 2001 on SSIs on the pretext of improving quality of medicines, SSIs were taken unawares as they were unable to object to the Draft Notification because their associations were non-existent. However, its implementation seemed easy and SSIs sought extensions. But as it has turned out, there is a total vacuum on information, interpretation and guidance on modifications to be carried out.
Consultants are so scarce that you can count barely 4 to 5 in the country. Hence they ask for exorbitant fee for the services. An SSI Unit having four sections has to pay at least Rs 5 lakh for consultancy alone. It has been realized that government has assumed the role of fault finder and not the facilitator, obviously because knowledge on implementation is lacking even at government level. It is obvious why such a law is sought to be implemented and at whose behest.
It is also realized that Schedule M virtually mandates SSI to raze factories to the ground and rebuild at a huge cost. To comply stipulations of space requirements in Schedule M, which even the WHO GMP does not mandate, the SSI should have extra land available, which is hard to come by as adjoining plots are already taken by others. Then there are stipulations of AHUs in every section, something that can be done if the height of the building can be increased to provide a service floor. Impossible compliance forced many to close down. For example 226 out of 1004 SSI units have been closed down by Maharashtra FDA alone, the letter said.
Ironically, results of Schedule M are also out now. Maharashtra has conveyed to Najma Heptullah Parliamentary Committee on Schedule M visiting Mumbai on 24 September 2007 that data of samples tested has been compiled to show how it has failed to guarantee quality. These facts have been taken on record by the Committee. Hence, Schedule M cannot be a quality assurance and some states authorities have been slow on implementation to save their SSIs in view of facts stated above, the SPIC letter said.