It’s aimed at strengthening the monitoring mechanism for the quality of drugs and will help in the robust and foolproof regulation of drug formulations
The database will improve monitoring mechanism for the quality of drugs in circulation across the country
By Tirtho Banerjee: The government has set up a seven-member high-level committee to prepare the first-of-its-kind ‘National Drugs Database’ in the country. It will provide comprehensive information about all drug formulations sold in India.
It comes a month after 66 children in Gambia died due to acute kidney injury from consuming a cough syrup made by Maiden Pharmaceuticals, a Haryana-based firm. The World Health Organisation (WHO) issued an alert after it was found that the killer syrups had “unacceptable” levels of diethylene glycol and ethylene glycol.
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The panel for the database has been constituted by the Central Drugs Standard Control Organisation (CDSCO) under the Union Health and Family Welfare Ministry’s Directorate General of Health Services.
The members of the committee are Dr HG Koshia, Commissioner of Food and Drug Control Administration (FDCA), Gujarat; AK Pradhan, Joint Drugs Controller (India), CDSCO; Dr Pooja Gupta, Additional Professor, AIIMS, New Delhi; Dr Jerian Jose, a scientist at the Indian Council of Medical Research, New Delhi; DR Gahane, Joint Commissioner of Food and Drug Administration (FDA), Maharashtra; BT Khanapure, State Drugs Controller, Karnataka, and Navneet Marwaha, State Drugs Controller, Himachal Pradesh. Pradhan will be the convener of the panel.
WHAT WILL THE COMMITTEE DO?
In the next three months, the committee will submit its recommendations after preparing a detailed database of drug formulations manufactured and marketed in the country. The database will contain all information about a drug, its dosage form, strength, and details of the manufacturer, marketer or importer. The panel will also cross-check the existing database with states and Union Territories’ drug control departments, manufacturers, distributors, and importers. This will help strengthen the monitoring process, and also ensure the quality and efficacy of medications.
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The memorandum to form the panel, dated October 27, 2022, was signed by the Drugs Controller General of India, VG Somani. It read: “A comprehensive database of drug formulations manufactured, marketed in the country providing detailed information on the drug, its dosage form, strength, details of manufacturer/marketer/importer etc is crucial…”
Such a database will not only “empower consumers” but also improve the “monitoring mechanism” for the quality of drugs in circulation across the country and the “uniform administration” of the regulatory system.
The committee may co-opt any other expert as deemed necessary, the memorandum added.
WHY IS THE DATABASE REQUIRED?
The database will go a long way in empowering the consumer to check the drug quality and its effectiveness. It will give him an informed choice. There will be checks on manufacturers that sell medicines which are not properly regulated and are sometimes overpriced. In the long run, it will do away with the duplicity of drugs — brands which sound or spell similar.
It will help implement good manufacturing practices in small companies, which, in turn, will help the consumer choose the right medicine.
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Currently, the Ministry of Health’s ‘Sugam’ provides a comprehensive database of the various permissions and licences issued by state drug regulators. This includes details of manufacturers, manufacturing sites and drug formulations.
The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have also entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. Moreover, National Pharmaceutical Pricing Authority (NPPA) oversees drug pricing and undertakes relevant studies.
However, these have fallen short of bringing about a foolproof and robust regulation of drug formulations due to various loopholes.
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The monitoring of pharma firms and drug manufacturing units has also faced challenges due to a shortage of staff. Sometime back, a Border Security Force (BSF) report said that India has just 1,500 drug inspectors responsible for more than 10,000 factories supplying medicines. Imagine there are only 140 such inspectors in West Bengal for 50,000 pharmacies.
Against such a backdrop, the National Drugs Database will be a giant step towards making drug companies and manufacturers adhere to the rule book. And this will ensure safety, rights and well-being of the consumers/patients.
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