23 Dec 2013

Drugs & Cosmetics (Amendment) Bill, 2013

Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare
The Drugs & Cosmetics Act, 1940 has been amended on several occasions since its enactment. On the last occasion, on the basis of the recommendations of the Mashelkar Committee, the Act was amended by the Drugs & Cosmetics (Amendment) Act, 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences were made cognizable and non-bailable.

 It also enabled setting up of special designated courts for speedy disposal of cases to deal with the cases of offences under the Drugs and Cosmetics Act. 16 States/UTs have already set up these special Courts. 

Recently, the Drugs & Cosmetics (Amendment) Bill, 2013 has been introduced in the Rajya Sabha on 29th August, 2013 to provide for inter alia creation of a Central Drugs Authority with powers to review, suspend and cancel the licenses issued by the Central and States’ Licensing Authorities, new Chapters containing regulatory provisions for medical devices and clinical trials, regulatory provisions for exports and centralized licensing in respect of 17 categories of drugs contained in a new Third Schedule. 

The Drugs & Cosmetics Rules, 1945 have been amended on numerous occasions. Recently, these rules were amended by three notifications, namely, 

(i) Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines; 

(ii) Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance; and 

(iii) Gazette Notification G.S.R No. 72(E) Dated 08.02.13 making registration of the Ethics Committees mandatory and specifying requirements and guidelines for registration of Ethics Committee. 

This was stated by Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha today. 

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