Drugs and Cosmetics Act, 1940 and

Rules, 1945

“DTAB, DCC and CDL- Constitution and Function”

“Administration of the Act & Rules”

• Drugs Technical Advisory Board

• Drugs Consultative Committee

• Central Drugs Laboratory

• Drugs Control Laboratories in state
• Government Analysts
• Licensing Authorities
• Controlling Authorities
• Drug Inspectors
• Customs Collectors
“DTAB”- Drugs Technical Advisory Board
Constitution :
 This Board was constituted by the Central Government.
 This Board shall consist of the following 18 members:

8 Ex- 5
officio elected

5 nominated
Ex-officio :
• Director General of
Health Services
(Chairman)
• Drugs Controller of India
• Director, CDL, Kolkata
• Director, CRI, Kasauli
• Director, IVRI, Izatnagar
• President, PCI
• President, MCI
• Director, CDRI,
Lucknow
Nominated : Elected :
• 2 persons- nominated by • A teacher- pharmacy or
Central Govt. amongst pharm. chem. or cognosy
persons incharge of drugs on staff of an Indian Uni
control in States or an affliated college-
• 1 person- nominated by elected by Executive
Central Govt. from committee of PCI
pharm. Industry • A teacher- medicine or
• 2 Govt. Analysts- therapeutics…….. MCI
nominated by Central • 1 pharmacologist- by
Govt. Governing body- ICMR
• 1 person- by Council of
CMA
• 1 person- Council of IPA
Functions :
 This Board was constituted with a purpose to advise the
Central and State Govts. on technical matters arising out of
the administration of Drugs and Cosmetics Act, 1940.
 Nominated and elected members hold the office for- 3
years and are eligible for re- nomination or re- election.
 Central Govt. appoints a Secretary and provides clerical
staff.
 The Board, with previous sanction of C. Govt., make by-
laws fixing quorum and regulating its own procedure and
the conduct of the business to be transacted by it.
 The Board may constitute sub-committees and appoint
temporary members for =< 3 years.
“DCC”- The Drugs Consultative Committee
Constitution :
 This advisory committee was constituted by the Central
Government.
 The committee shall consist of the following members:

2 Representatives
of the Central
1 Representative
of each State
Government Government
Functions :
 This committee was formed in order to secure uniformity
in the D&C, Act 1940 throughout India.
 It advises the Central Govt., State Govt., and even
DTAB on matters tending to secure uniformity.
 The DCC meets when required by Central Govt.
 Empowered to regulate its own procedure.
“CDL”- The Central Drugs Laboratory
Established in Kolkata,
CDL is the national
statutory laboratory of the
Government of India.
It is under the control of a
Director appointed by the
Central Government.
 It is the oldest quality
control laboratory of the
Drug Control Authorities in
India.
Procedure :
Enclosed with a
Samples sent by the court
memorandum in Packet and outer cover
for analysis to the CDL
prescribed form , in an marked with a
by a registered post in a
outer cover addressed to distinguished number
sealed packet
the Director

A copy of memorandum
On receipt of the packet,
The condition of the seal and specimen impression
it should be opened by an
on the packet to be of seal sent separately by
authorized person on
recorded registered post to the
behalf of the Director
Director

Certificate issued by CDL

should be signed by the
Result of test to be sent to
Director or any officer
the sender
authorized by the Central
Govt. on his behalf
Functions :
 To analyze drugs and cosmetics samples sent by Customs
Collector or Courts.
 Analytical Quality Control of the imported samples.
 Any other duties entrusted by the Central Government.
 Preparations of reference standards and their
maintenance.
 Maintenance of microbial cultures.
 Acting as an appellate authority in matter of disputes.
“References”
 www.cdsco.nic.in
 “Pharmaceutical Jurisprudence”, Jani GK, Atul Prakashan,
Fifth Edition- 2005-06; 28.
 “A textbook of Forensic Pharmacy”, Jain NK, Vallabh
Prakashan, Eighth thoroughly revised edition; 147-149.
 "India's Central Drugs Standard Control Organization
(CDSCO)". Pacific Bridge Medical. Dec 29, 2012.
Retrieved Dec 29, 2012.