India’s Pharmaceutical Reputation Under Scrutiny

Context:

India, often referred to as the pharmacy of the global South, is facing a serious crisis of reputation due to recent incidents involving contaminated and unapproved drugs.

Alarming Drug Contamination Cases

Several cases of substandard medicines produced by Indian pharmaceutical companies have led to fatalities across different countries, raising global concerns.
- Toxic Cough Syrups: Cough syrups made by Indian companies, containing dangerous amounts of diethylene glycol and ethylene glycol, were linked to the deaths of 66 children in Gambia, 65 in Uzbekistan (2022), and 12 in Cameroon (2023).
- Contaminated Eye Drops: Indian-made eye drops contaminated with drug-resistant bacteria led to three deaths and eight cases of blindness in the U.S. (2023).
Criminal Actions in West Africa: A BBC investigation uncovered that Aveo Pharmaceuticals, a Maharashtra-based company, was manufacturing and exporting unapproved opioid drug combinations to West Africa.
- The combination of tapentadol (a powerful opioid) and carisoprodol (a muscle relaxant) had not been approved for use together, violating drug safety regulations.

Regulatory Failures

Illegal Drug Combinations: The drug combination of tapentadol and carisoprodol was being exported without approval from the Central Drugs Standard Control Organization (CDSCO), which is the authority for novel fixed-dose combination drugs in India.
State Drug Authorities’ Role: Although State drug authorities can approve standalone drugs, they cannot authorise new drug combinations without CDSCO clearance. Despite this, there is a pattern of State authorities ignoring this regulation.

Action Taken by Authorities

Regulatory Response: After the BBC investigation provided video evidence of Aveo Pharmaceuticals’ illegal activities, Indian authorities swiftly took action. The CDSCO and State regulatory authority:
- Seized nearly 13 million illegal medicines and 26 batches of active pharmaceutical ingredients.
- Issued a ‘stop activity’ order, withdrawn the manufacturing license, and banned exports of the dangerous drug combination.
- Issued a show cause notice to the company.
Need for Stringent Punishment: While regulatory action was taken, experts stress that only stringent punishment will serve as a strong deterrent to prevent future violations and protect public health.