c
 




  


  

Thursday, October 27, 2005 08:00 IST

c

All regulatory aspects related to import, manufacture, sale and advertisements of drugs in India are covered under three
separate enactments, namely, Drugs & Cosmetics Act 1940 and the Drugs & Cosmetics Rules 1945, The Pharmacy Act
1948 and the Drugs & Magic Remedies (Objectionable Advertisements) Act 1954.

Drugs & Cosmetics Act

The Drugs and Cosmetics Act 1940 is a central legislation, which regulates the import, manufacture, distribution and sale of
drugs and cosmetics in the country. The main objective of the Act is to ensure that the drugs available to the people are safe
and efficacious and conform to prescribed quality standards and the cosmetics marketed are safe for use. The Drugs Act
was enacted in 1940. The Drugs Rules were promulgated in December 1945 and the enforcement of these statutes started
in 1947. The Drugs Act, as enacted in 1940, has since been amended several times and is now titled as Drugs and
Cosmetics Act. The Rules have also been amended from time to time to meet the needs of the times and to make good any
deficiencies noticed during the implementation. The very definition of 'Drug' under the Drugs & Cosmetics Act covers a wide
variety of therapeutic substances, diagnostics and medical devices.

Recently, the central government notified 10 medical devices as drugs that requires central clearance prior to import,
manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are
cardiac stents, drug eluting stents, catheters, intra ocular lenses, I V Cannulae, bone cements, heart valves, scalp vein set,
orthopaedic implants and internal prosthetic replacements.

Under the Constitution of India, 'Drugs' being a concurrent subject, the responsibility of enforcing the various provisions of
the Act vests with the Central Government and the State/UT Governments. The roles of Central & State Governments are
well defined.

Pharmacy Act 1948

The Pharmacy Act was enacted for the regulation of the profession and practice of pharmacy in the country. The Act has led
to the formation of the Pharmacy Council of India (PCI) which regulates the functioning of pharmacy education institutions
through state pharmacy councils. PCI is also the statutory body to register pharmacy graduates, thereby turning them
eligible for practicing as community pharmacists.

Drugs & Magic Remedies (Objectionable Advertisements) Act 1954

Drugs and Magic Remedies Act talks about controlling the advertisement of drugs in certain cases, to prohibit the
advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected
therewith. State drug regulators are the enforcement agencies of D &MR Act.

Central Drug Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General (India) (DCGI)
discharges the functions allocated to Central Government. The CDSCO is attached to the office of the Director General of
Health Services in the Ministry of Health and Family Welfare. The DCGI is a statutory authority under the Drugs Act and has
port offices, zonal offices and drug testing laboratories functioning under him.

The main functions of the Central Government are approval of new drugs to be introduced in the country, permission to
conduct clinical trials, registration and control on the quality of imported drugs, laying down regulatory measures and
amendment of Acts and, Rules, laying down standards for drugs, cosmetics, diagnostics and devices, and updating Indian
Pharmacopoeia, approval of Licenses as Central License Approving Authority for manufacture of large volume parenterals,
vaccines and biotechnology products and operation of blood banks and also of such other drugs as may be notified by
Government from time to time. It also coordinates the activities of the States and advising them on matters relating to
uniform administration of the Act and Rules in the country.
The State Governments are responsible for licensing of manufacturing establishments and sales premises, carrying out
inspections of licensed premises for ensuring compliance to conditions of licenses, drawing samples for test and monitoring
the quality of drugs and cosmetics moving in the State, taking appropriate actions like suspension / cancellation of licenses,
surveillance over sale of spurious / adulterated drugs, instituting legal action, wherever needed, as provided in the Act and
Rules and to monitor objectionable advertisements pertaining to drugs. The State Drug Controllers exercise these functions
through State Drugs Inspectors. The organizational set up varies widely from State to State. While in some States, a full time
technical person heads the drug con trol Organization, the others have administration or medical persons as ex-officio drug
controllers or heads of offices.

Capacity Building Programme

The latest development in the area of drug regulation is the launch of an ambitious World Bank supported Capacity Building
Programme. Already underway, the programme envisages the setting up of a world class Food and Drug Administration
Headquarters in Delhi. The construction of the Administrative Building is considered as a physical and psychological
milestone due to its symbolic significance as the first step for a uniform food and drug administration.

The total cost of the project is about Rs.355 crores of which the multilateral funding agency will provide more than Rs.236
crores. The building itself is to cost Rs.11.74 crores and will be ready in about in 2006.

The Food and Drug Administration Bhawan will house the offices of CDSCO and the Food Division of DGHS, Ministry of
Health and Family Welfare. The FDA Bhawan would ensure better interface of Drug and Food Authorities with the public and
other stakeholders. The programme also envisages country wide training programmes for regulators, analysts and small
scale pharmaceutical companies for better enforcement and compliance of the laws
 ]




  ]




 





  



Statutory Functions Statutory Functions
Laying down standards of drugs, cosmetics, Licensing of drug manufacturing and sales
diagnostics and devices. establishments.
Laying down regulatory measures, amendments to Acts Licensing of drug testing laboratories.
and Rules.
To regulate market authorization of new drugs. Approval of drug formulations for manufacture.

To regulate clinical research in India. Monitoring of quality of Drugs & Cosmetics,

manufactured by respective state units and those
marketed in the state.

To approve licenses to manufacture certain categories Investigation and prosecution in respect of

of drugs as Central Licence Approving Authority i.e. contravention of legal provisions.
for Blood Banks, Large Volume Parenterals and
Vaccines & Sera.

To regulate the standards of imported drugs. Administrative actions.

Work relating to the Drugs Technical Advisory Board Pre- and post- licensing inspection.
(DTAB) and Drugs Consultative Committee (DCC).

Testing of drugs by Central Drugs Labs. Recall of sub-standard drugs.

Publication of Indian Pharmacopoeia.

Other Functions
Coordinating the activities of the State Drugs Control
Organizations to achieve uniform administration of the
Act; and policy guidance.

Guidance on technical matters.

Participation in the WHO GMP certification scheme.

Monitoring adverse drug reactions (ADR).

Conducting training programmes for regulatory
officials & Govt. Analysts.
Distribution of quotas of narcotic drugs for use in
medicinal formulations.
Screening of drug formulations available in Indian 

market.
Evaluation/Screening of applications for granting No
Objection Certificates for export of unapproved/banned
drugs.