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​Not business as usual: On upholding India’s reputation for quality drugs

2 min read

Pharmacy Crisis in the Global South

The reputation of the pharmacy sector in the global South, particularly India, is under severe scrutiny due to recent incidents involving harmful pharmaceutical products.

Incidents of Harmful Products

  • Several tragic incidents have tarnished India's pharmaceutical reputation:
    • In 2022, cough syrups with unacceptable amounts of diethylene glycol and/or ethylene glycol resulted in the deaths of 66 children in Gambia and 65 in Uzbekistan.
    • In 2023, similar syrups caused 12 child fatalities in Cameroon.
    • Contaminated India-made eye drops led to three deaths and eight cases of blindness in the U.S. in 2023.

Aveo Pharmaceuticals Case

  • A BBC investigation exposed the criminal activities of Aveo Pharmaceuticals, a Maharashtra-based company:
    • The company exported unapproved opioid drug combinations to West Africa containing tapentadol and carisoprodol.
    • These combinations, although containing individually approved drugs, were not approved by the Central Drugs Standard Control Organization (CDSCO).

Regulatory Failures and Actions

  • Regulatory lapses have been identified:
    • State drug authorities bypassed legal provisions by issuing licences for unapproved drug combinations.
    • The Health Ministry frequently bans Fixed Dose Combinations (FDCs) due to such oversights.
  • In response to the BBC investigation:
    • The CDSCO and State authorities took action even without a formal complaint from West African nations.
    • A significant seizure of nearly 13 million medicines and 26 batches of active ingredients was made.
    • Actions included halting production, revoking export permissions, and issuing a show cause notice.

Call for Stringent Measures

  • Authorities stress the need for strict penalties to deter illegal activities in the pharmaceutical industry.
  • India must uphold its reputation for producing high-quality generic drugs and avoid gaining notoriety for manufacturing harmful drugs.
  • Tags :
  • Pahramacy Crisis
  • Generic Drugs
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