New rules ease testing for drug imports from US, EU, Australia, and Japan

Under new guidelines, testing will be reduced to one sample every two years or one sample from 20 consecutive consignments, whichever comes first

The government has introduced new guidelines to reduce the frequency of drug testing for imports from countries such as the US, Australia, Japan, Canada, and the European Union, provided their drug samples have maintained a clean record with no quality failures in the past five years, according to a report by The Economic Times.

Under these guidelines, testing frequency will be reduced to either one sample from every two years' worth of consignments or one sample out of every 20 consecutive consignments, whichever occurs first, according to the Central Drugs Control Organisation (CDSCO).

To maintain drug quality, random testing will be conducted on one consignment every six months or one out of 10 consecutive consignments, whichever comes first. If any sample fails a quality check, testing must be carried out on the next five consecutive consignments. Drugs from new suppliers are required to undergo mandatory testing. If a product fails, importers will have the choice to either send the goods back to the country of origin or destroy them under supervision by an assistant drugs controller or customs officer.

 

In addition to these measures, CDSCO has increased random inspections of pharmaceutical facilities across the country to ensure quality control.

The government has also issued a guidance document for port officials, advising them on how to monitor imported drug quality through a risk-based approach at the point of entry.

Cough syrups fail quality check

According to a report by the CDSCO, cough syrup samples from over 100 pharmaceutical manufacturers in India failed to meet quality standards.

These batches were labelled as "not of standard quality" (NSQ) due to contamination issues involving diethylene glycol (DEG), ethylene glycol (EG), assay inconsistencies, microbial contamination, improper pH levels, and incorrect volumes.

The report, submitted to the Ministry of Health and Family Welfare, revealed that out of 7,087 batches tested, 353 were found to be NSQ, with nine batches posing significant concerns due to the presence of diethylene glycol and ethylene glycol.

Furthermore, the report highlighted that some of the samples contained the same toxic substances found in cough syrups linked to child fatalities in The Gambia, Uzbekistan, and Cameroon.