Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Indian biotech investigated following deaths of Uzbek children


From UPSC perspective, the following things are important :

Prelims level: NA

Mains level: Challenges to Indian pharma sector

The Central Drugs Standards Control Organisation (CDSCO) are investigating Noida-based firm after the deaths of 18 children in Uzbekistan by drinking health syrup contaminated with Diethylene Glycol (DEG).

India’s response to these deaths

  • It is certainly the responsibility of the importing country to test medicines before releasing them in their market.
  • After being informed about the incident, India’s apex regulatory body, Central Drugs Standard Control Organisation (CDSCO) opened investigations and lifted control samples.

Issue: India’s credibility at stake

  • India is one of the leading exporters of medicines.
  • PM Modi recently stressed that Indian drugs had earned the world’s trust and that India could be called the ‘pharmacy to the world’.
  • However, such negative reports on the quality and safety of our medicines will be a massive blow to the country’s image as a source of cheap generic drugs to the world.

Issues highlighted by the incident

  • Smuggling of cheap drugs: Inquiry reveals that these were imported from an Indian manufacturer, not under public tender but privately.
  • Ignorance by authorities: The drug which is banned for domestic consumption has got exported and led to fatalities. This is a huge blissful mistake by Indian Authorities.
  • Lack of inspection: There are not enough drug inspectors in the country to conduct as many inspections as is ideally required in such as vast set-up.
  • Inadequacies in quality-check: Despite huge production units, there are not an adequate number of laboratories to test the samples in time if all the samples that should be lifted for testing are picked up.
  • Blot on credibility: The matter, if not properly handled, can damage the perception that Indian medicines are trustworthy for many countries and the global South.

Possible factors behind this tragedy

  • There are rackets of counterfeit Indian medicines turning up in many countries.
  • Some of these were coming from unregistered producers in India, who would produce medicine depending on what cost was paid to them without concern for quality.
  • In some cases, competitors from other countries were known to make counterfeit medicines with Indian markings and dump them in markets where Indian pharmaceuticals were well regarded.

Way forward

  • The pharmaceutical trade is vital and must be protected from predatory practices and violations of regulatory norms.
  • Regulatory mechanism on both sides should be strengthened.
  • Importers should be given lists of recognised Indian manufacturers.
  • Training should be provided to drug controllers to curtail the menace of counterfeit and poor-quality medicine entering from India.

Back2Basics: Diethylene Glycol (DEG)

  • A/c to WHO, Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal.
  • It can cause kidney and neurological toxicity and has been associated with several cases of mass poisoning when consumed via drugs.
  • The chemical tastes sweet and is water-insoluble.
  • The toxic effects of the chemical include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury.


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