The Indian Drug Manufacturers Association (IDMA) has appealed to the Union Railway Ministry to remove the Rs 50 crore turnover restrictions imposed on pharma companies for participating in the Railway tenders for supplying medicines to different hospitals under the Indian Railways. The restrictions, based on the Railways' concern over the quality of medicines, will tantamount to denial of opportunities to thousands of small scale pharma units in the country who comply with strictest quality norms, IDMA pleaded.

Terming the Rs 50-crore restriction of the Indian Railways as grossly discriminatory to the SSIs who comply with the strictest GMPs as the latest Schedule M guidelines and other quality norms, IDMA said such reservations would only work against the survival and growth of SSIs who are the pioneers and backbone of our economy and hence should be given adequate and fair opportunity to compete and participate in the purchase of the tenders.

The IDMA pleaded that purchase of medicines based on annual turnover of companies would on its own never guarantee quality. Turnover alone cannot guarantee quality of medicines when many manufacturers get their products manufactured from different factories and on contract from small scale and medium scale units. The rigorous regulatory requirement of Good Manufacturing Practices (GMP) under the revised Schedule M of the Drugs and Cosmetics Act and Rules is followed by all manufacturers. The manufacturers also strictly follow the norms as per the Indian Pharmacopoeia. This being so, all manufacturers having GMP certificate produce medicines of the desired quality.

Expressing shock over the Railways decision, the IDMA said that as long as any interested manufacturer produces quality medicines at competitive prices and manufactures the same under valid licenses issued by the regulatory authorities, no restrictions as being large or small units or sales or annual turnover should be considered as a pre-qualification for applying for the tenders. Such discriminatory policies discourage SSIs instead of encouraging them to grow, it said.

For the last 2-3 decades all the pharma companies, especially SSIs , have had the opportunity and have been supplying medicines to the different hospitals under Railways. Railways have been purchasing these medicines on basis of registration of firms. Tenders for medicines are still being issued to various firms on the basis of registration and representation among the doctors of the hospitals. Many small scale pharma units are providing quality medicines at a reasonable price to Railway hospitals all over the country.

IDMA asked the railway ministry to frame suitable policies which would encourage and protect the SSI without compromising the quality standards. Such a gesture will greatly support the SSI manufacturers to perform better and ensure supply of quality medicines to the poor and needy patients in all the remote areas of our country, IDMA said.