The World Health Organization (WHO) has recently issued an alert pertaining to four cough syrups manufactured in India that are reportedly linked to acute kidney injuries in children and have caused 66 fatalities in The Gambia, a small West African country. The products under question were found to contain unacceptable quantities of diethylene glycol and ethylene glycol, both unapproved in food or drugs due to their potential to induce abdominal discomfort, vomiting, diarrhea, headaches, severe renal injury, and neurological toxicity. It’s noteworthy that these products were not sold domestically in India and were exclusively created for approved export markets as authorized by the Drugs Controller General of India (DGCI).
Regulation of Drugs in India: Understanding the Norms
Drugs and Cosmetics Act, 1940 and Rules 1945 lay down the responsibilities of central and state regulators concerning drug and cosmetic regulation. This act sets a regulatory framework for issuing licenses to manufacture Ayurvedic, Siddha, and Unani medicines. Compliance with the act’s prescribed requirements for the licensing of manufacturing units and medicines, including safety and effectiveness proof and adherence to Good Manufacturing Practices (GMP), is mandatory.
Role of Central Drugs Standard Control Organization (CDSCO)
CDSCO plays a significant part in standardizing measures to ensure the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices. One of its many roles includes market authorization of new drugs and establishing standards for clinical trials. Moreover, CDSCO also oversees drug imports and approves licenses to manufacture medical products. Within the export regulations, any manufacturer holding a certification from CDSCO can export drugs from India.
Drugs Controller General of India (DCGI): The Driving Force
At the helm of CDSCO is the Drugs Controller General of India (DCGI), entrusted with the approval of licenses for specific categories of drugs such as blood and blood products, IV fluids, vaccines, and sera. The DCGI not only establishes standards for manufacturing, sales, import, and distribution of drugs in the country but is also accountable for supervising their execution.
The recent alert by the WHO concerning Indian manufactured cough syrups underscores the importance of strict regulatory norms and their enforcement to ensure safety, efficacy, and quality of medical products. These regulations are critical in maintaining public trust in the pharmaceutical sector and in maintaining India’s international reputation as a significant pharmaceutical player.
