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 The Karnataka Drug Controller has withdrawn licences of two combination products last week.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. Indian Drug Manufacturers Association, being the representative body of several medium and small drug manufacturers, has objected to DCGI directive on legal grounds. Definition of new drugs under Rule 122(E) was incorporated into the Drugs & Cosmetics Rules on September 21, 1988. IDMA's stand, therefore, is that FDCs approved by the State Licensing Authorities prior to that date cannot be classified as new drug under Rule 122 (E). From the legal point of view, IDMA may have a point to raise. But the issue here is the therapeutic rationale of these fixed dose combinations and their safety. It is wrong to argue that these combinations have been in the market for several years and therefore they should be allowed to remain in the market. The whole objective of DCC'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.