Govt starts drug inspection drive

The campaign follows several reports of the sale of spurious and substandard medicines. The recent controversy involving Maiden Pharmaceuticals Ltd’s cough syrup, which was linked to the deaths of 66 children in Gambia, sparked concerns about the quality of Indian drugs.

Preventing the distribution of subpar drugs is crucial to maintaining India’s reputation as the “pharmacy of the world”. India has seen drug exports more than double to $24.5 billion in the past decade. The deaths in Gambia dented India’s reputation, although India asserted that the drugs produced by Maiden were not responsible. However, a Gambian parliamentary panel recently said that Maiden’s cough syrup was responsible for the deaths of the children due to acute kidney injury.

“We are conducting a special drive to inspect pharmaceutical companies. Our drug regulators are visiting every drugmaker for an inspection. However, regulatory testing of drugs and medicines keeps on happening. I read multiple news reports on spurious and subs-standard medicines that were being found here and there. So, I instructed the agencies to conduct a special drive on it,” health minister Dr Mansukh Mandaviya said in an interview.

An action plan for nationwide inspection of manufacturing units which are identified to be at risk of making drugs classed as Not of Standard Quality (NSQ), adulterated or spurious was prepared prior to carrying out inspections. The Drugs Control Administration is required to ensure that manufacturing units comply with the Drugs and Cosmetics Act, 1940, and the rules thereunder, especially the requirements of Good Manufacturing Practices (GMP).

On Tuesday, the union health ministry said the Central Drugs Standard Control Organization (CDSCO) has started conducting joint inspections of drug manufacturing units along with state drugs control administration as per a risk-based approach.

“We have initiated the action to inspect the pharma units. We have identified two such drug manufacturing units. There is a proper proforma based on which we conducted the drive-in coordination with the central government. Very soon, we will be able to submit our report to the CDSCO,” said K.R. Chawla, Delhi Drugs Controller.

During the winter session of the Parliament, Bharati Pravin Pawar, minister of state health and family welfare, told Rajya Sabha that around 84,874 drug samples were tested in 2020-21, out of which 2,652 samples were declared Not of Standard Quality (3.12%), and 263 were declared spurious while 0.31% of drugs were adulterated.