1. Drugs & Cosmetics Amendment
Bill 2013
Major Changes
Dr. Bhaswat S. Chakraborty

2. Regulatory Impact Analysis
• Need for the regulatory action?
• How the regulatory action will meet that need?
• An appropriate baseline (i.e., best assessment of how
the world would look in the absence of the proposed
action).
• Based on reasonably obtainable scientific, technical,
and economic information and is it presented in an
accurate, clear, complete, and unbiased manner?
• Benefits from the regulatory action?
• Costs implications?

3. Current D&C Act: Amended up to 2005
• Chapter I: Introductory – scope, definitions etc.
• Chapter II: The Drugs Technical Advisory Board, The Central
Drugs Laboratory & The Drugs Consultative Committee
• Chapter III: Import of Drugs & Cosmetics
• Chapter IV: Manufacture, Sale and Distribution of Drugs and
Cosmetics
• Chapter IVA: Provisions Relating to Ayurvedic, Siddha & Unani
Drugs
• Chapter V: Miscellaneous
• Schedules including Schedule M (2001) and Schedule Y (2005)

4. Major Amendments Proposed in
2013 Bill
• Insertion of 3 subchapters
– Chapter 1A – Constitution of Central Drugs
Authority (expanded multi-level authority)
– Chapter 1B – Clinical Trials (permission &
penalties)
– Chapter IIA – Import, Manufacture, Sale,
Distribution and Export of Medical Devices

5. Chapter 1A – Constitution of Central
Drugs Authority
• 13 member category Authority including Health &
Family Welfare and DCGI
• 11 member categories are ex officio
• Only 1 category of membership (4 experts) will
require relevant expertise
• Only 1 category of membership (4 officers) of State
Licensing Authorities
• These two categories will have a tenure of 3 years;
can be renominated

6. Chapter 1A – Constitution of Central
Drugs Authority..
• Declaration of conflict of interest by members and nonparticipation in such cases.
• Vacancies, defective nominations etc., not to invalidate
proceedings.
• The appointment, salaries, allowances and pensions
payable to the DCGI shall be determined by the Central
Government.
• Necessary staffing for Central Drugs Authority will be
created by the Central Government in consultation with
the former.
• Powers and functions of Central Drugs Authority have
been described

7. Principal Powers and functions of
Central Drugs Authority
• (a) issue, renew, suspend or cancel licences or
certificates or import, export or manufacture of drugs,
cosmetics or medical devices or clinical trials;
• (b) recall or direct to recall any drug, cosmetic or
medical device;
• (c) collect the fees or charges for issue or renewal of
licences, certificates, approvals and permissions issued
by the Central Licensing Authority;
• (d) discharge any other functions as may be assigned
to him by the Central Drugs Authority;

8. Other Responsibilities
• DCGI shall have administrative control over the officers
and employees of the Central Drugs Authority.
• Central Government will grant the Central Drugs
Authority sums of money as are required by it.
• Accounts and audits will be maintained by the Central
Drugs Authority.
• The Central Drugs Authority shall issue an annual report
every year.
• Will have power to make relevant rules and regulations.

9. Chapter 1B – Clinical Trials
• No clinical trial without permission.
• (1) No person shall initiate or conduct any clinical trial in
respect of a new drug or IND or medical device or device
IND or cosmetic or BE study of any drug in human
subjects without permission by Central Licensing
Authority.
• (2) No person shall initiate or conduct any clinical trial
without an Ethics Committee approval.
• (3) No person shall initiate or conduct any clinical trial
before it is registered with the Central Drugs Authority.

10. Other Stipulations re Clinical Trials
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Injury or death, whether caused by the trial shall be decided by the DCGI.
Medical treatment and compensation due to injury in clinical trials will be decided by DCGI.
The Central Licensing Authority may, in public interest, abbreviate, defer or omit the pre-clinical
and clinical data requirements for approval of clinical trials.
Registration and composition of Ethics Committees and action against EC in case of its failing to
discharge its proper function.
Inspection by Drugs Control Officer with or without prior notice into any premises related to
clinical trial is to be allowed by the sponsor or trial site authority.
Disclosure of name, address, etc., of persons involved in clinical trials & maintenance of records
and furnishing of information.
Penalty for conducting clinical trials without permission, e.g., 3-5 years imprisonment and/or
fine up to ten lakh rupees.
Penalty for repeat offence and Penalty for violation of conditions of permission.
Penalty for failure to provide compensation and Penalty for contravention of any provision of
this chapter.
Confiscation of stock of the drug or devise as well as the machineries etc. for conducting clinical
trials.
Cognizance of offences by authority or victim.
Powers of central government to make rules about clinical trials.
This Chapter not to apply to Ayurvedic, Homeopathy, Siddha or Unani drugs.