The Indian Drug Manufacturers Association (IDMA) has demanded the Northern Railways to drop its conditions of turnover criteria and WHO GMP certification for registration of pharmaceutical companies to supply medicines for the railway hospitals and health units under the Northern Railways for the next three years.

Pharmabiz learnt that in a recent advertisement, the Northern Railways had laid down 14 odd clauses, including the condition of a minimum annual turnover of Rs 15 crore in the last three years to supply routine products and Rs 100 crore or more for life saving drugs and advanced antibiotics, besides WHO-GMP certification for the production unit and WHO-COPP for each specific product.

Other clauses included details like R&D facilities and progress of research at the labs, list of original molecules or formulations developed by the firm, details of supply order for last three years and performance report attested by government organizations, relevant information on specific products as per ORG-MARG analysis or similar reputed report, a list of developed countries where the firm has been supplying the item in the case of overseas firms which authorize local companies, five year track record as a manufacturer and three year market standing for the product etc. It is also mandatory for the firms to have a registered office or branch office in Delhi. The advertisement said it is also desirable to have ISO certification, USFDA and UK - MCP approval for manufacturing plants and processes for specific products, CECDC certification for sale in developed countries or similar national or international certification etc.

Reacting to this on complaints from many IDMA members, in a letter addressed to Dr. D K Das, director general - RHS of Northern Railways, the IDMA said the turnover clause and WHO GMP certification would deny opportunity for many SSI manufacturers to participate in the tender, and hence these clauses should be withdrawn.

He noted that as per clause 5 of the circular (No.F.No.22 (1)/2003/E.P & N dated 29/07/03, issued by the development commissioner of SSIs, the office of the Jt. Development Commissioner of SSIs, minimum turnover should not be made mandatory as an eligibility clause for tenders, and price and quality should be the criteria. According to the circular -'issues of concern to buyer are the quality and price of the product. Turnover is immaterial and putting eligibility condition of minimum turnover with a threshold of crores of rupees in tenders discriminate against SSI industries. Hence the mandatory eligibility clause of minimum turnover should not be imposed for SSI units in tenders for procurement of the materials.'

IDMA also noted that the DCGI circular (D.O.No.CDSCO/NZ/JDC (S) to all State Drug Controllers had said the procurement agencies in India should ask only for GMP certificate instead of the WHO GMP certificate. "COPP which describes the level of GMP compliance as per WHO norms is required only for the procurement agencies of International Committee, not for domestic market. The procurement agencies in India therefore may ask for GMP certificate, relates to compliance of revised Schedule M of Drugs and Cosmetics Rules and not for COPP (WHO GMP)," the DCGI had mentioned, noted IDMA.

It is learnt that the Railways is yet to respond to the IDMA letter dated July 21,2004. The advertisement appeared a few days ago and had mentioned 30 days time for registration.

It may be noted that IDMA recently intervened in a similar issue related to the purchase of drugs by the drug-procuring agency of the health department in Karnataka. Following IDMA's persuasion and a direct communication from the Development Commissioner of SSIs, New Delhi, the Karnataka Government diluted the clauses related to mandatory WHO -GMP certification in the tender process, said sources.