Combination drugs are a crime on society by the drug manufacturers of the country shots and determined to remove this crime from the society which has been going on for the last over 10 years said Drugs Controller General of India (DCGI) Dr M Venkateshwarlu .
Over the issue of most of the combination drugs being described as irrational drugs, DCGI denied that he had ever described them as irrational. Further he said that DCGI is ready to solve the ambiguity over the rationality, stability and efficacy of these drugs.
In the initial stages it was a minor aberration which was harmless and nobody took notice of it. But things have now come to such a pass that the drug market is filled with combination drugs which are harmful to the patients.
The move to weed out irrational combination drugs from the market is facing resistance from the pharmaceutical producers as the Drug Controller General of India issued a directive on August 14 to state drug controllers for taking necessary action. The directive was issued by DCGI following the stand took by the Drug Consultative Committee while reviewing the magnitude of this problem a few weeks ago.
India is having several thousands of fixed dose combinations in the market without any therapeutic rationale and safety profile. The office of the DCGI has been trying to bring some control on the uncontrolled growth of FDCs for some years now but without any success. Most of these FDCs available in the market are approved by State Drug Licensing Authorities and not by DCGI. These FDCs are considered to be new drugs under Rule 122 (E) (c) of the Drugs & Cosmetics Rules, 1945 and all new drugs have to be approved by the DCGI. While issuing the directive on August 14, DCGI also forwarded 4 lists of FDCs to the state drug controllers asking them to withdraw licenses of all such products. Now, the ball is in the court of the state drug controllers, as they are the enforcement authorities.
Instant action from the state drug controllers on this issue should not be expected and has not been forthcoming also. Acting on the DCGI directive would mean that the state drug controllers will have to undo what they have been doing for several years as licensing authorities. The state drug controllers of Maharashtra and Karnataka have, however, initiated action a few days ago. Maharashtra FDA issued instructions to stop production of 330 combination drugs and recall the products from the market. Of the DCGI's list of 1067 combination drugs, licences for 330 products were issued by the Maharashtra FDA over last 10 years. The state FDA chief has directed all the 7 joint commissioners in the state to enforce the order. The Karnataka Drug Controller has withdrawn licences of two combination products last week. An inevitable outcome of the enforcement of the DCGI order is withdrawal of several products from the market. Many of them are well established brands of even reputed companies. It will certainly lead to a drop in the overall sales of some of the companies.
The whole objective of DCGI's exercise was how to weed out harmful combination drugs from the market and not to legalise or regularise their existence by way of some interpretations.