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बेसिक इंग्लिश का दूसरा सत्र (कक्षा प्रारंभ : 22 अक्तूबर, शाम 3:30 से 5:30)
Q. Overhaul drug regulation: Discuss the need to fix the India’s fragmented drug regulation system.
Sep 28, 2016 Related to : GS Paper-2

Ans :


Currently drug regulation system in India is suffering from various issues. Many health blowers and health activists claimed that India’s approval and regulatory system for drugs and pharmaceuticals is dysfunctional. These activists points out various shortcomings and glaring anomalies in our drug and pharmaceuticals oversight system. These issues need urgent and prompt rectification.


  • Currently Indian drug regulatory framework is heavily fragmented. India has about 36 (one for each State and UTs) licensing authorities. There is no coordination between these authorities.
  • In the absence of proper coordination pharma manufacturer can garner a licence in one state and distribute its product nationally.
  • Any laxity in the drug regulation can have national and even international repercussions. For example laxity in a batch of Not of Standard Quality (NSQ) drug has repercussions.
  • Recently some reports showed that substandard and NSQ drugs can be as high as a fifth or more of all medicines procured locally.
  • The Central Drugs Standards Control Organisation and the state authorities are supposed to carry out routine testing of drug samples, but the recent study found that the statistical methodology followed to be vague and mostly non transparent.

What needs to be done?

  • We need to overhaul the India’s drug and pharmaceutical oversight regime more urgently as India is witnessing high growth in pharma sector.
  • India must adopt efficient mechanism to ensure a nationwide withdrawal of a bad batch once it is established as being NSQ in a particular state.
  • A more centralised system must be created by amending the Drugs & Cosmetic rules and regulations.
  • Similarly a national NSQ database must be established to vet credibility of manufacturers.
  • A public procurement law must be formed to regulate and mandate standards in the procurement of medicine.


In recent times India is witnessing high growth in pharmaceutical sector, but our regulatory mechanism is suffering from various issues. Hence there is urgent need to cope up with growing need and to fix the all issues associated with regulatory mechanism. A proactive pharma regulatory reform would boost wellness, trade and the overall growth momentum of India.

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