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Indian-made Drugs Issues UPSC NOTE


Indian-made drugs issues

  • Deaths of two patients in Sri Lanka who were administered Indian-made anaesthetic drugs.

  • Last month, eye drops manufactured in India had caused eye infection in about 30 patients and blindness in 10 in Sri Lanka.

  • The series of adverse reports against drugs produced in India began last year when the World Health Organization (WHO) linked the deaths of at least 70 children in Gambia from acute kidney injury, to cough syrups.


  • The culprit ingredient in the syrups was diethylene glycol and ethylene glycol — deadly chemicals used as a cheaper substitute for propylene glycol — that should never have been found in any medicine.

  • Soon after the deaths in Gambia, cough syrups made in India and containing the two deadly chemicals killed 18 children in Uzbekistan in December 2022. 

  • Diethylene glycol-contaminated drugs have led to at least five incidents of poisoning in Chennai, Mumbai, Bihar, Gurugram and Jammu between 1972 and 2020.


  • In end-April this year, Indian-made cough syrup was again in the news when WHO flagged the contaminated drugs found in the Marshall Islands and Micronesia; the contamination was identified by the Australian regulator. 

  • Even after serious violations, Indian drug regulator gave a clean chit to the company that had supplied the drugs to Gambia and then went on the offensive to fault the global health body.

  • Except for some customary inspections, the Indian drug regulator has so far failed to institute measures to make sure drugs produced in India for export and domestic use are safe. 


  • India can continue to be the pharmacy of the global south only if the regulator begins to behave like a watchdog to ensure drug safety, and not as a facilitator for the pharma industry.

Central Drugs Standard Control Organisation (CDSCO)

  • CDSCO is the National Regulatory Authority of India for cosmetics, pharmaceutical and medical devices. 

  • The CDSCO – comes under the Directorate General of Health Services, Ministry of Health and Family Welfare.


  • CDSCO is responsible for the 

    • Approval of drugs 

    • Conduct of clinical trials

    • Laying down the standards for drugs

    • Control over the quality of imported drugs in the country 

    • Coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.


Pharma Exports from India

  • India’s pharmaceutical exports have continued to rise, hitting $25.3 billion (approximately Rs 2,08,231 crore) during the fiscal year 2022–23.

  • With a 20% volume share, India is the largest generic drug provider in the world. 

  • Government statistics show that India’s pharmaceutical exports more than doubled during the 2014-2022 period.



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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: Indian-made Drugs Issues UPSC NOTE
Indian-made Drugs Issues UPSC NOTE
Learnerz IAS | Concept oriented UPSC Classes in Malayalam
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