Drugs and Cosmetic Rules 1945 | Central Drugs Standard Control Organization 10/07/2019 – Posted in: Daily News

DRUGS AND COSMETIC RULES 1945

 

For: Mains

Topics covered: Amendments to Drugs and Cosmetic Rules, 1945, Generic Medicines, Central Drugs Standard Control Organization

 

News Flash

The Central Government is considering amendments to the Drugs and Cosmetic Rules, 1945.

 

Background

The matter was recently brought before the Drugs Consultative Committee (DCC) of the CDSCO.

  • DCC was apprised that registered medical practitioners can supply different categories of medicines including vaccines.
  • They do so to their patients under the exemption provided, with certain conditions, under Schedule K of the Drugs and Cosmetics Rules, 1945.
Schedule K: Contains various substances and drugs and their corresponding regulation.

 

  • As of now, there are no specified types of medicines that can be supplied by doctors to their patients.

Proposed amendments

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

 

Generic Medicines

  • A generic drug is a pharmaceutical drug.
  • It contains the same chemical substance as a drug that is originally protected by patents.
  • Generic drugs are allowed for sale after the patents on the original drugs expire.
  • Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.

 

Significance

  • The amendment will ensure that registered medical practitioners dispense only generic medicines.
  • The government also has to ensure easy availability, unclogged supply chain, and strict quality control of generic medicines.
  • The move will keep drugs affordable.

 

Drugs and Cosmetics Rules, 1945

  • The Drugs and Cosmetics Rules, 1945 are the set of rules under The Drugs and Cosmetics Act, 1940.
  • It contains provisions for the classification of drugs under given schedules.
  • It also contains the guidelines of drugs for their storage, sale, display, and prescription of each schedule.

 

Central Drugs Standard Control Organization (CDSCO)

  • CDSCO is the National Regulatory Authority (NRA) of India.
  • Its headquarter is in Delhi.
  • The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for the regulation of drugs & cosmetics.
  • It envisages the uniform implementation of the Act & Rules for ensuring the safety, rights and well being of the patients.

Under the Drugs and Cosmetics Act:

CDSCO is responsible for:

  • 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
  • Bring out the uniformity in the enforcement of the Drugs and Cosmetics Act.

 

Source: The Hindu

 

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