Drug Regulator Collates Data Of Pharma Plants To Ensure Safety And Quality
The Drug Controller General of India (DCGI) has taken significant steps to enhance drug quality and safety within the pharmaceutical industry. In response to a government campaign against spurious and substandard drugs, the DCGI has initiated the collection and compilation of profiles for pharmaceutical plants across India. Pharmaceutical companies are now required to furnish detailed information about each of their operational units in the country.
These companies must provide data on their international approvals, including those obtained from regulatory bodies like the European Union, US Food and Drug Administration, Japan”s Pharmaceuticals and Medical Devices Agency, and the Brazilian Health Regulatory Agency (Anvisa). For companies involved in exports, they must disclose the names of the importing countries, details of their overseas units, and whether they possess a World Health Organization-Good Manufacturing Practice certificate. Additional information such as annual turnover, domestic turnover, export turnover, and production capacity is also part of the data collection process.
India boasts approximately 10,500 units engaged in manufacturing various dosage forms and active pharmaceutical ingredients, according to data from the Central Drugs Standard Control Organisation. The DCGI has issued a letter dated September 4 instructing state drug controllers to collaborate with the companies under their jurisdiction to acquire these crucial details. This initiative aims to comprehensively assess the status of manufacturing units in India, identify the products intended for the domestic and export markets, and gather essential information.
Over the past fiscal year, there have been 494 new plant approvals and 1,682 licenses granted to new units that commenced production. Earlier this year, the government conducted raids on more than 75 pharmaceutical companies in several states, identifying over 25 companies in violation of regulations and issuing show-cause notices. These actions were part of the DCGI”s efforts to clamp down on spurious and substandard drugs, resulting in the closure of non-compliant companies.
Recent months have witnessed instances of Indian pharmaceutical products exported abroad failing to meet quality standards. The World Health Organization (WHO) highlighted cases where contaminated cough and cold syrups produced by an Indian drug manufacturer were linked to children”s deaths in Gambia due to kidney injuries. These developments highlights the importance of stringent regulations and data collection efforts by the DCGI to ensure the safety and quality of pharmaceutical products in India.
