209 Pharma companies under Govt lens over violations

At the national level, 71 firms have been issued show-cause notices and 18 ordered closed.

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Audit, Inspection, Documents , medicine FDA
Picture: Pixabay

Last Updated on July 16, 2023 by The Health Master

The Union Government data reveals that out of 209 pharma companies being subjected to inspections by drug regulators following red flags over Indian medicines abroad:

  • Himachal Pradesh (71),
  • Uttarakhand (46),
  • Madhya Pradesh (23),
  • Gujarat (16),
  • Punjab (7),
  • Maharashtra (5),
  • Tamil Nadu (5),
  • Delhi have (5),
  • Haryana (4),
  • Karnataka (4),
  • Telangana (4),
  • West Bengal (3),
  • Rajasthan (1),
  • Sikkim (1),
  • UP (1),
  • Puducherry (1),
  • Kerala (1),
  • Andhra Pradesh (1),
  • Bihar (1),
  • Goa (1),
  • J&K (1).

Top sources told that so far, joint teams of the Central Drug Standards Control Organisation (CDSCO) 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.

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

Drug Alert: NSQ Drugs Lists – Updated

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