After Cough Syrup Deaths, CDSCO Tightens Oversight on Drug Testing Compliance
IPC
New Delhi: In the wake of the tragic child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has issued a strong directive to all State and Union Territory Drug Controllers, calling for strict enforcement of the Drugs Rules, 1945, with specific emphasis on the mandatory testing of raw materials and finished pharmaceutical products.
In an official communication, the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, emphasized that manufacturers must test every batch of raw materials, including excipients and active pharmaceutical ingredients (APIs)—as well as the finished formulations before their release to the market.
The directive comes in the backdrop of inspection findings that exposed serious lapses by certain manufacturers, who failed to conduct the required batch-wise testing of raw materials and finished formulations, in violation of Rules 74(c) and 78(c)(ii) of the Drugs Rules, 1945.
It is noted that during the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products.
In addition to the above, the Drugs Controller General of India (DCGI) stated,
"It is to mention that as per the Drugs Rules, including rule 74 (c) and rule 78 (c) (ii), the licensee shall, either in his own laboratory or in any laboratory approved by the licensing authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U."
Accordingly, the Drugs Controller General of India (DCGI) directed,
"All State and UT Drug Controllers be instructed to monitor compliance during inspections, issue sensitization circulars to manufacturers, and ensure that companies maintain robust vendor qualification systems. Manufacturers have also been told to procure raw materials only from approved and reliable suppliers."
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