Action Taken to Remove Hazardous Products from Market: India Implements Stringent Measures to Safeguard Public Health
In a recent development, the World Health Organization (WHO) issued alerts regarding three cases of syrup products exported from India, raising concerns about their safety and quality. Responding swiftly to the alerts, the Central Drugs Standard Control Organization (CDSCO) collaborated with State Drug Controllers to conduct joint investigations into the matter.
Violation of Good Manufacturing Practices Leads to Show Cause Notice
One of the investigations in Haryana uncovered a serious violation of Good Manufacturing Practices (GMP) by M/s Maiden Pharma. In response to this finding, the State Drugs Controller, Haryana, issued a show cause notice to the company under Rule 85(2) of the Drugs Rules, 1945. Additionally, immediate orders were given to halt all manufacturing activities of M/s Maiden Pharmaceuticals at Sonipat.
Manufacturing License Suspended and Arrests Made in Uttar Pradesh
Another investigation conducted by CDSCO and the State Drugs Controller in Uttar Pradesh revealed irregularities at M/s. Marion Biotech Pvt. Ltd., Noida. Following the investigation, the manufacturing license of the company was suspended by the State Licensing Authority. In a parallel development, an FIR was lodged against the company, leading to the arrest of three individuals.
Quality Concerns in Marshall Islands & Federated States of Micronesia
CDSCO, in coordination with the State Drugs Authority, Punjab, conducted a joint investigation at M/s QP Pharmachem Ltd., Punjab, which exports to the Marshall Islands & Federated States of Micronesia. Drug samples were drawn from the manufacturing premises and declared “Not of Standard Quality.” Consequently, the State Licensing Authority directed the firm to cease all manufacturing activities immediately.
Regulatory Measures to Ensure Drug Quality
To ensure the quality of medicines in the country, the CDSCO and Ministry of Health and Family Welfare have implemented several regulatory measures. These include stringent penalties for the manufacture of spurious and adulterated drugs, the establishment of special courts for drug offenses, and an increase in the number of sanctioned posts in CDSCO.
Emphasis on Drug Efficacy and Safety
To enhance drug efficacy and safety, amendments have been made to the Drugs and Cosmetics Rules, 1945. Applicants are now required to submit evidence of stability and safety of excipients before the grant of manufacturing licenses. Additionally, the submission of bioequivalence study results is now mandatory for certain oral dosage forms.
Export Policy Amendment for Cough Syrups
To safeguard the quality of exported cough syrups, the Directorate General of Foreign Trade has issued a notification mandating cough syrup manufacturers to obtain a certificate of analysis from a government-approved laboratory before exporting their products.