Pharma MSMEs demand guidelines for data on standard quality drugs; health ministry considering proposal

A proposal to issue guidelines for releasing data of drugs declared standard quality (SQ) by Central Drugs Laboratory (CDL), and Regional Drugs Testing Laboratory (RDTL) has been created following a representation by Laghu Udyog Bharati, an MSME network, Pharmabiz reported.

This data will follow bi-monthly information of not-of-standard quality (NSQ) drugs released by the Central Drugs Standard Control Organisation (CDSCO).

Further, reports indicated that the Ministry of health and family welfare is actively considering this proposal. This proposal was sent to the health ministry by Drugs Controller General of India (DCGI).

Amit Chawla, Director, McW Healthcare, said that the NSQ data leaves the Indian drug industry in a bad shape. Pharmabiz quoted him saying, “The NSQ data is less compared to the numbers of drugs declared SQ by CDL and RDTL, but it gives an opportunity to a section of people to raise a hue and cry about the quality of drugs manufactured by the Indian drug industry.”

Chawla, who is also Vice-President of Laghu Udyog Bharati Indore unit and Secretary of Madhya Pradesh Small Scale Drug Manufacturers Association, added,

To instill confidence in people that a majority of drugs marketed in the country is safe for consumption, we have constantly demanded the release of SQ drug data.”

Earlier in March, pharma MSMEs sought financial support and a phase-wise implementation of the health ministry's proposed revision of good manufacturing practices under Schedule M of the Drugs and Cosmetics Rules, 1945 at par with WHO-GMP guidelines.

According to the proposed revision, changes in Schedule M provisions would not apply to presently licensed manufacturers until October 31, 2020.

In the same month, pharma MSMEs were also concerned about the approaching deadline for implementation of labelling change for drugs. They called upon the health ministry to carry over its implementation by a year to salvage them from incurring a loss, which could go over Rs 300 crore due to a huge buildup of packing material stocks.

ALSO READ:

Pharma SMEs seek a year-long deadline extension to implement new labelling norms for drugs

How Nagpur-based Cureveda creates herbal supplements and connects people for free with 5,000 doctors