The health ministry in India conducted wide-ranging inspections across the pharmaceutical industry and found multiple deficiencies among drug manufacturers. The inspections were intensified after some cough syrups were linked to the deaths of at least 95 children overseas.
The risk-based inspections covered 162 factories and 14 public laboratories, revealing various issues, including lack of raw materials testing, poor documentation, absence of self-assessment, and inadequate quality failure investigation. Additionally, some drugmakers lacked measures to avoid cross-contamination, had a shortage of professionally qualified employees, and had faulty design in manufacturing and testing areas.
India’s pharmaceutical industry, valued at Rs 3.39 lakh crore, is known globally for providing affordable alternatives to western products. However, the recent cough syrup-related deaths have impacted its reputation.
In response to the findings, the government has halted production at four drugmakers after contaminants were identified in their cough syrups by agencies like the World Health Organization. The companies involved deny any wrongdoing.
To address the deficiencies, the health ministry upgraded the ‘Good Manufacturing Practices’ under the Drugs and Cosmetics Rules. This upgrade includes the introduction of quality risk management, product quality review, supplier audit and approval, and equipment validation. Large drug manufacturers have been given six months, and small manufacturers have been given 12 months to transition to the upgraded manufacturing requirements.
Furthermore, India has increased testing of cough syrup exports, making it mandatory for companies to obtain a certificate of analysis from a government laboratory before exporting products. This move aims to enhance the safety and quality of pharmaceutical exports from the country.
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