209 pharma units under govt lens over violations, 71 in Himachal Pradesh

Tribune News Service

Aditi Tandon

New Delhi, June 20

Himachal Pradesh drug industry is under active scanner of the Centre and the apex drug regulator for violations of medicine safety standards with as many as 71 of India’s 209 firms shortlisted for risk-based inspections housed in the hill state alone.

The Union Government data sourced by The Tribune reveals that out of 209 firms being subjected to inspections by drug regulators following red flags over Indian cough syrups and medicines abroad, 33 per cent (71) are in Himachal Pradesh, followed by Uttarakhand (46), Madhya Pradesh (23), Gujarat (16) and Punjab (seven). Maharashtra, Tamil Nadu and Delhi have five each; Haryana, Karnataka and Telangana four each; West Bengal three; Rajasthan, Sikkim, UP, Puducherry, Kerala, Andhra Pradesh, Bihar, Goa and J&K one each.

Top sources told The Tribune today that so far, joint teams of the Central Drug Standards Control Organisation and state drug controllers had conducted inspections of 125 of the 209 drug companies.

At the national level, 71 firms have been issued show-cause notices and 18 ordered closed. Two phases of the inspections, aimed at addressing concerns around the quality of drugs produced in India and exported, have happened so far and the third phase is ongoing.

In the two phases, 51 of Himachal’s 71 shortlisted drug manufacturing units have been inspected. Of these, 26 have faced show-cause notices; 11 have faced stop-production orders until evidence of improvement in good manufacturing practices comes and two units are facing cancellation of licence. Top Union Health Ministry officials said 84 firms across India are still to be inspected for quality. Of these, 20 are in Himachal Pradesh alone.

The risk-based inspections follow three instances of Indian drugs being red flagged abroad. In February 2023, Chennai-based Global Health Care recalled artificial tear drops exported to the US after US FDA flagged serious adverse events. In December 2022, 18 Uzbek children died after allegedly consuming contaminated cough syrups made by Noida-based Marion Biotech. In October 2022, nearly 70 Gambian kids died of alleged potential contamination of syrups made by Maiden Pharma.

How the defaulting units were identified

• List of 209 firms made, each with over 11 ‘not of standard quality’ (NSQ) failures
• In Phase 1, 78 firms, each with 20 and above NSQs, selected for joint inspection
• For Phase 2, the next 47 firms, each with 15 to 19 NSQs, selected on the basis of intelligence
• Three additional firms selected based on complaints and intelligence inputs

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