What is the National Drug Database and how will it help consumers?

It aims to strengthen the drug quality monitoring mechanism and will contribute to sound and foolproof regulation of drug formulations

The database will improve the mechanism for monitoring the quality of medicines in circulation throughout the country

By Tirtho Banerjee: The government has set up a high-level committee of seven members to prepare the country’s first “National Drug Database”. It will provide complete information on all drug formulations sold in India.

This comes a month after 66 children in The Gambia died of acute kidney injury from consuming a cough syrup made by Maiden Pharmaceuticals, a Haryana-based company. The World Health Organization (WHO) has issued an alert after it discovered killer syrups had “unacceptable” levels of diethylene glycol and ethylene glycol.

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The database panel was put together by the Central Drug Standards Control Organization (CDSCO) under the Health Services Branch of the Union Ministry of Health and Family.

The committee members 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, Scientist, Indian Council of Medical Research, New Delhi; DR Gahane, Joint Commissioner of the Food and Drug Administration (FDA), Maharashtra; BT Khanapure, National Drug Controller, Karnataka, and Navneet Marwaha, National Drug Controller, Himachal Pradesh. Pradhan will be the organizer of the panel.

WHAT WILL THE COMMITTEE DO?

Over 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, distributor or importer. The panel will also cross-reference the existing database with state and union territory drug control departments, manufacturers, distributors and importers. This will help strengthen the monitoring process and ensure the quality and efficacy of medicines.

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The memorandum to form the panel, dated October 27, 2022, was signed by the Comptroller General of Drugs of India, VG Somani. It said, “A comprehensive database of drug formulations manufactured, marketed in the country providing detailed drug information, dosage form, strength, manufacturer/marketer/importer details, etc. is crucial… “

Such a database will not only “empower consumers”, but also improve the “monitoring mechanism” of the quality of medicines in circulation throughout the country and the “uniform administration” of the regulatory system.

The committee may co-opt any other expert deemed necessary, the memorandum adds.

WHY IS THE DATABASE NEEDED?

The database will go a long way in empowering the consumer to verify the quality and efficacy of the drug. This will give him an informed choice. Checks will be carried out on manufacturers who sell drugs which are not properly regulated and which are sometimes too expensive. In the long run, this will eliminate drug duplicity – brands that look or spell the same.

This will help implement good manufacturing practices in small businesses, which in turn will help the consumer to choose the right drug.

READ ALSO | No confirmation yet whether Indian-made cough syrup killed 70 children: Gambia government

Currently, the Ministry of Health’s “Sugam” provides a comprehensive database of the various authorizations and licenses issued by national drug regulatory authorities. This includes details of manufacturers, manufacturing sites and drug formulations.

The Medicines and Cosmetics Act 1940 and the Medicines and Cosmetics Rules 1945 also assigned various responsibilities to central and state regulators for the regulation of medicines and cosmetics. Additionally, the National Pharmaceutical Pricing Authority (NPPA) oversees drug pricing and undertakes relevant studies.

However, these have failed to put in place foolproof and robust regulation of drug formulations due to various shortcomings.

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Oversight of pharmaceutical companies and drug manufacturing units has also encountered difficulties due to a lack of personnel. A Border Security Force (BSF) report some time ago stated that India had only 1,500 drug inspectors responsible for over 10,000 factories supplying drugs. Imagine there are only 140 such inspectors in West Bengal for 50,000 pharmacies.

In such a context, the national drug database will be a giant step towards the adherence of pharmaceutical companies and manufacturers to the regulations. And it will ensure the safety, rights and well-being of consumers/patients.

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