Business

India Intensifies Pharma Inspections to Ensure Drug Quality

In a concerted effort to enhance the quality of domestically manufactured medicines and eliminate counterfeit drugs, Indian regulatory authorities have conducted risk-based inspections at over 500 pharmaceutical production facilities since 2022.

• By Newsdesk
• New Delhi
• Feb 24, 2025

Business

In a concerted effort to enhance the quality of domestically manufactured medicines and eliminate counterfeit drugs, Indian regulatory authorities have conducted risk-based inspections at over 500 pharmaceutical production facilities since 2022. Sources indicate that these inspections will persist as part of a broader initiative to uphold stringent manufacturing standards.

According to official data, more than 400 enforcement actions have been taken against non-compliant manufacturers. These actions include issuing show cause notices, halting production, and suspending or revoking manufacturing licenses. The Central Drugs Standard Control Organisation (CDSCO) reports that India houses approximately 10,500 pharmaceutical units producing various dosage forms and active pharmaceutical ingredients (APIs).

Several instances of Indian pharmaceutical exports failing to meet international quality standards have raised concerns. The World Health Organization (WHO) linked the deaths of dozens of children in Gambia in 2023 to contaminated cough and cold syrups produced by Indian manufacturers, further highlighting the need for stricter oversight.

"The government has been conducting raids on pharmaceutical companies across different states. Those found in violation of regulations have been issued show cause notices," a senior official stated under conditions of anonymity. The government is closely monitoring multiple drug manufacturers as part of its ongoing regulatory crackdown.

Current regulations mandate the swift recall of any pharmaceutical products deemed defective or potentially harmful. The Indian drug regulator has also emphasized the urgent need to review and enhance Good Manufacturing Practice (GMP) regulations and quality management systems to ensure pharmaceutical companies comply with international safety standards.

As the government continues its rigorous inspections, the pharmaceutical industry faces mounting pressure to adhere to stricter quality controls, reinforcing India's commitment to ensuring drug safety and maintaining its reputation as a global pharmaceutical hub.