Govt to set up national drugs database to monitor quality, Health News, ET HealthWorld

Govt to set up national drugs database to monitor quality

Mumbai: The government is setting up a comprehensive database of drug formulations manufactured and marketed in the country to strengthen the monitoring mechanism and plug loopholes in the regulatory system.

This seems to be corrective action being taken by the government to address the issue of quality monitoring and regulatory policing, after the deaths of kids in Gambia last month, experts say.

Some 66 children died after the consumption of cough syrups made from “sub-standard toxic ingredients’’ by a little-known domestic firm, Maiden Pharma.

Questions have been raised on quality control, implementation of good manufacturing practices in small companies, and policing by regulators.

The government has constituted an expert panel to prepare a `National Drugs Database’ which will list the information on the drug, its manufacturer or marketer, dosage forms and strengths, official sources told TOI.

At present, there is no comprehensive national database which provides all details on drugs. The Ministry of Health maintains `Sugam’, an index of drug licenses issued to companies by state FDAs, while drug prices regulator NPPA separately collects data on companies for price control.

Since it is not mandatory for companies to provide details, none of the government agencies have been successful in collecting accurate and robust data.

A comprehensive database is crucial not only to empower consumers, but also to improve the monitoring mechanism for ensuring quality and efficacy of drugs, a government notification accessed by TOI said. It could also help in the uniform administration of drug regulation across the country.

The seven-member committee comprises HG Koshia, commissioner Food and Drugs Control Administration (Gujarat), AK Pradhan joint drugs controller (India), Pooja Gupta additional professor AIIMS (New Delhi), Jerian Jose scientist ICMR, and DR Gahane joint commissioner FDA (Maharashtra). State drug controllers from Karnataka and Himachal Pradesh are also members of the panel. The committee will examine existing databases available with multiple state and Central regulatory authorities, manufacturers and importers, the notification adds.

It is expected to submit the recommendations including the national database of drug formulations in three months.

The implementation of regulations has been a challenge with 3,000-odd companies and over 10,500 manufacturing units, leading to ineffective policing and gaps in quality monitoring. This is compounded by a massive shortage in personnel and funding of the Central and state drug regulatory mechanism, experts added.

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