• NPPA'S HELPLINE NO. 1800111255

Quality Control and Rational Use of Drugs

1. Quality Control and Rational Use of Drugs are important aspects of Pharmaceutical Industry. Steps have been taken for strengthening Drug Control Organization by sanctioning additional posts at various levels and by establishing subzonal 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.

2. 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, packagings have been standardized. Five leading hospitals at Pondicherry, Chandigarh, New Delhi, Bombay and Lucknow have been identified as Adverse Drug Reaction Monitoring Centres.

3. 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.