|
Alarmed by the latest fiasco related to quality standards of cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has directed all drug controllers in the States and Union Territories (UTs) to ensure testing of raw materials and excipients before manufacturing and release of the batch to the market.
The central drug regulator in a communication to the State and UT drug controllers, pointed out that there have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to quality of the cough syrups.
It added that during the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality (NSQ), "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".
"This Directorate has time to time emphasized the critical importance of testing of raw materials including the excipients before its use in the manufacturing of pharmaceutical formulations," it said.
In this context, the CDSCO also mentioned that as per 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.
"All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc." said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).
"Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only," added the official.
According to reports, at least seven children died in Madhya Pradesh owing to kidney failure, allegedly due to contaminated cough syrup in the recent weeks, while adverse reactions were also reported in Rajasthan owing to administration of some drugs.
Following the reports earlier this month, the central and state drug regulators swung into action by testing samples not only in Madhya Pradesh, but also in other states. The Union Ministry of Health stated that Risk Based Inspection has been initiated on October 3, at the manufacturing premises of all the 19 drugs sampled, spread across 6 states.
It also informed that none of the samples tested in Madhya Pradesh contained contaminants that known to cause serious kidney injury. However, it has not revealed details of the 19 drug samples and the manufacturing premises it conducted RBI on.
Samples of Coldrif Cough Syrup tested by the drug regulator from Sresan Pharma in Kanchipuram, Tamil Nadu, turned out to contain diethylene glycol (DEG) beyond the permissible limit, according to the Union Health Ministry.
The Central drug regulator recommended cancellation of the manufacturing license of the manufacturer of cough syrup Coldrif, based on inspection findings. Criminal proceedings have also been initiated, said the authorities.
A High-Level meeting convened by the Union Health Ministry with State Government officials and officials from health, drug regulatory authorities also emphasised strict compliance with the revised Schedule M - revised Good Manufacturing Practices (GMP) - by all drug manufacturers and strict action against those do not comply with the standards.
|