Quality Control and Rational use of Drugs
13. Quality Control and Rational use of Drugs are important aspects of Pharmaceutical
Industry. Steps have been taken for strengthening Drug Control
Organisation by sanctioning additional posts at various levels and by
establishing sub-zonal offices at Hyderabad, Ahmedabad and Patna. The
Bio-Laboratory at Madras has been upgraded to the level of National
Laboratory. The Central Drugs Laboratory at Bombay, functioning from 1992
is in the process of being upgraded while Regional Laboratories at
Guwahati, Chandigarh and Hyderabad are in the process of being set up. To
improve the existing State Drugs Testing Laboratories and to set up new
ones, wherever not established, funds have been sanctioned under a
Centrally Sponsored Scheme, besides providing funds under this scheme for
augmenting Drug Inspectorate Staff. For certain categories of drugs, which
had caused adverse effects due to the lack of drug control in one or the
other State, the Central Government has taken upon itself the
responsibility of granting license. These drugs are; (i) Large Volume
Parenterals, (ii) Sera and Vaccines and (iii) whole Human Blood and Blood
Products. Moreover, the Good Manufacturing Practices (GMP) have been made
mandatory.
14. Screening of irrational or harmful drugs is an ongoing exercise and 44 categories of
formulations have been banned so far and the definition of new drugs has
been widened and guidelines issued on clinical trials. With a view to
ensuring proper dispensing and rational use of drugs, packaging have been
standardised. Five leading hospitals at Pondicherry, Chandigarh, New
Delhi, Bombay and Lucknow have been identified as Adverse Drug Reaction
Monitoring Centres.
15. While
Ministry of Health and Family Welfare are taking some action on these
matters, the general perception unfortunately is that this area is
presently being neglected. In the interest of the consumers, there cannot
be any compromise on quality aspects of medicines and the problem has
assumed greater dimension in view of the large number of small scale drug
manufacturing units which are estimated to be over 8000 in
number.
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