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Drugs and Cosmetic Rules, 1945

Topic covered:

Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

Drugs and Cosmetic Rules, 1945


What to study?

For prelims and mains: Generic drugs- significance, concerns, usage and efforts by the government to promote them.


Context: The Central Government is considering amendments to the Drugs and Cosmetic Rules, 1945 to ensure that registered medical practitioners dispense only generic medicines.



A proposal was recently received by the Central Drugs Standard Control Organisation (CDSCO) committee wherein the Drugs Consultative Committee (DCC) was apprised that registered medical practitioners can supply different categories of medicines including vaccines to their patients under the exemption provided, with certain conditions, under Schedule K of the Drugs and Cosmetics Rules, 1945. As of now there are no specified types of medicines which can be supplied by doctors to their patients.

It is now proposed that registered medical practitioners shall supply generic medicines only and physicians samples shall be supplied free of cost.


What is a Generic Medicine?

Generic medicines are unbranded medicines which are equally safe and having the same efficacy as that of branded medicines in terms of their therapeutic value. The prices of generic medicines are much cheaper than their branded equivalent.


Why are they cheaper?

Since the manufacture of these generic drugs do not involve a repeat of the extensive clinical trials to prove their safety and efficacy, it costs less to develop them. Generic drugs are, therefore, cheaper.

However, because the compounds in the generic versions have the same molecular structure as the brand-name version, their quality is essentially the same.


Why aren’t generic drugs more popular?

Lack of awareness about them.

Since they are cheap, people who can afford branded drugs don’t buy them believing them to be of inferior quality. Chemists have to hand out exactly what’s written on the prescription and most doctors except in government hospitals don’t hand out generic drugs.

Also, private doctors never hand out generic drugs because there are no kickbacks or incentives involved from pharma companies.

The government or specifically the government’s Department of Pharmaceuticals is also to blame for the lack of awareness.


However, there are three fundamental areas of concern:

  1. Efficacy of Indian-made drugs: Oftentimes, such drugs have been found to contain less than the required amount of active pharmaceutical ingredient (API), rendering them ineffective.
  2. Lack of data integrity: The poorly managed documentation practices of Indian generic firms featured as the primary criticism flagged by foreign regulatory authorities. The lack of reliable and complete data on the test results of specific drug batches, along with inconsistencies in the records presented, meant that inspection and verification of drug quality was extremely difficult.
  3. Hygiene standards of the manufacturing plants: Individuals suffering from illness are especially susceptible to infections, and inspections of generic drug plants reveal pest infestations and dilapidated infrastructure.


Various efforts by the government:

Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ is a campaign launched by the Department of Pharmaceuticals, Govt. Of India, to provide quality medicines at affordable prices to the masses through special kendra’s known as Pradhan Mantri Bhartiya Jan Aushadhi Kendra.

Bureau of Pharma PSUs of India (BPPI) is the implementing agency of PMBJP. BPPI (Bureau of Pharma Public Sector Undertakings of India) has been established under the Department of Pharmaceuticals, Govt. of India, with the support of all the CPSUs.

Sources: the Hindu.

Mains Question: Discuss merits and demerits of compulsory prescription of generic medicines.