Drug Inspection Drive: Show cause notices have been sent to some pharma firms of Himachal

The drive is being carried out following several reports of sale of counterfeit and substandard medicines. The recent controversy surrounding Maiden Pharmaceuticals Ltd’s cough syrup that killed 66 children in Gambia raised concerns about the quality of Indian medicines.

The Union Health Ministry on Tuesday said that the Central Drugs Standard Control Organization (CDSCO) has started joint inspection of drug manufacturing units with state drug control administrations under a risk-based approach.

A total of six teams have been formed to conduct audits and inspections at Indian pharmaceutical manufacturing units News18 Report.

More than 12 drug manufacturing units have been raided in Himachal Pradesh so far, some companies have been sent show cause notices and manufacturing in one unit has been completely suspended. News18 Report. Some organizations in Uttar Pradesh and Uttarakhand have also violated the rules of drug manufacturing.

Preventing the distribution of substandard drugs is important for maintaining India’s reputation as the “Pharmacy of the World”. India has seen pharmaceutical exports more than double to $24.5 billion in the past decade.

The deaths in Gambia tarnished India’s reputation, although India insisted that the drugs produced by Maiden were not responsible. However, a Gambian parliamentary panel recently stated that Maiden’s cough syrup was responsible for the children’s death due to acute kidney injury.

An action plan for the whole country inspection of manufacturing units Medicines that are identified as being at risk of manufacturing drugs classified as Standard Quality (NSQ) were prepared prior to being inspected, adulterated or counterfeit.

The Drug Control Administration needs to ensure that the manufacturing units comply with the requirements of the Drugs and Cosmetics Act, 1940 and the regulations made thereunder, particularly the Good Manufacturing Practices (GMP).