The Central Drug Standards Control Organization (CDSCO) headed by
the Drugs Controller General (India) is the Central Authority for regulating
the quality of drugs marketed in India under the Drugs and Cosmetics Act,
1940. It is the regulatory body within
India that is responsible for approval of new drugs, clinical trials, laying
down the standards for drugs, control over the quality of imported drugs,
coordination of the activities of state drug control organizations and
providing expert advice with a view to bring about the uniformity in
enforcement of various provisions of the Drugs and Cosmetics Act, 1940 and
Rules thereunder. Regulation of manufacture, sale and distribution of drugs is
however primarily the concern of the state drug controlling authorities. A total
of 1125 new drugs have been approved for marketing and use within India by
CDSCO between January, 1961 and January, 2013 that includes single ingredient
as well as combination formulations.
Among the combination drug formulations largest number of drugs
have been approved for acute pain, inflammation, musculoskeletal spasm (52);
hypertension (46); nutritional disorders (40); RTI, UTI, ENT infections (29).
Among the single ingredient formulations largest number of drugs have been
approved for Cancers (56); acute pain, inflammation, musculoskeletal spasm
(39); GIT disorders (24); RTI, UTI, ENT infections (22). Therefore these are
the areas inviting maximum attention of the regulatory authorities within India
with respect to approval of new drugs over the past five years. Still a vast
number of other areas remain unattended and there is need to diversify the
types of drugs being approved in India with special attention to Orphan
diseases. Further the approval process itself needs to be made more stringent
as pointed out by a parliamentary panel appointed by the Govt. of India for the
purpose of investigating the process of approval of new drugs by Central Drug
Standards Control Organization of India.
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