Centre to review safety, efficacy norms for 13 ‘very old’ drugs

New Delhi: The government body charged with setting quality standards for drugs has launched a review of the safety and efficacy norms for 13 commonly used but “very old” drugs and asked pharmaceutical companies to submit their manufacturing licence approval letters.

The Indian Pharmacopoeia Commission (IPC), part of the Drugs Controller General of India, said the letter should be issued by either the Central Drugs Standard Control Organisation (CDSCO) or a state licencing authority.

The Commission is set to incorporate new standards into Indian Pharmacopoeia—the handbook that lists efficacy and safety standards for all drugs produced in the country that companies have to follow.

The 13 drugs include Clindamycin Lotion used for skin allergies, Nitrofurantoin Oral Suspension used to treat infections of the bladder and Dexamethasone, used to treat inflammation of the skin, joints, lungs and other organs. The details have to be furnished by Friday, 28 February.

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“Indian Pharmacopeia Commission in the process of incorporating new monographs into the Indian Pharmacopoeia. To facilitate this inclusion, IPC has requested the pharma companies to submit a copy of the CDSCO approval/State Licensing letter, for around 13 products. 

These drugs are very old products and may have been approved 30-40 years ago. People are already manufacturing and selling in the market. Right now, the intention is to see how these drugs are doing, when was it approved and what IP standards the manufacturers are following,” said an official familiar with the matter.

India is moving towards self-reliance in the pharmaceutical sector. Government allocation for medicines and medical devices has shot up by 29% from ₹4,090 crore in FY24-25 to ₹5,269 crore in the recent union budget.

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In FY23-24, pharma exports earned $26.5 billion compared with imports of $7.1 billion. India is the 3rd largest producer of medicines by volume.

Indian Pharmacopeia standards are the official standards under the Drugs and Cosmetics Act. Manufacturers must comply with it, and any deviations can lead to legal consequences. It also ensures quality control in terms of drug identity, purity, and strength, legal enforceability, patient safety, transparency and consistency, and research and development.

“Whenever a manufacturer is producing a drug, the product must comply with the standards set by the Indian Pharmacopeia Commission. It also specifies the number of tests to be done before the release of the drug in the market. Also, whenever the drug inspector draws samples and sends them to the laboratory for testing, labs also use those standards for testing,” said the official.

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Patients from around the world, including from developed countries, have been coming to India in growing numbers for medical treatment, for which hospital chains primarily use medicines that are made in India.

India is the biggest supplier of medicines to UN agencies. More than half of the exports are to markets under stringent regulations such as the US, EU and Japan.

Queries sent to the health ministry spokesperson remained unanswered.