Above: Drugstores will now have clarity about FDCs/Photo: 1ohww.org

With the health ministry banning the manufacture, sale and distribution of 328 drugs, the endless battle between it and the manufacturers seems to have exploded

By Dr KK Aggarwal

The battle between the government and manufacturers of certain drugs has finally come to a head with the health ministry banning the manufacture, sale and distribution of 328 fixed dose combination (FDC) drugs with immediate effect and restricting six others. Among the brands that may be affected are painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ.

This was a festering issue for many years. In May 2012, the Parliamentary Standing Committee on Health and Fa­mily Welfare in its 59th Report observed that some of the State Licensing Authorities had issued manufacturing licences for a large number of FDCs without prior clearance from the Central Drugs Standard Control Organisation (CDSCO). It recommended that a clear and transparent policy be framed for approving FDCs. On February 3, 2014, CDSCO constituted 10 different committees for examination of applications. By notifications dated March 10, 2016, the central government banned the manufacture and sale of 344 FDCs. Following this, many writ petitions were filed before the Delhi High Court and on December 1, 2016, the Court stayed the ban on all these items.

However, on December 15, 2017, the apex court set aside the Delhi High Court judgment and said: “We say so because we find that the Kokate Committee did deliberate on the 344 FDCs plus 5 FDCs and did come to a conclusion that the aforesaid FDCs be banned, but we are not clear as to what exactly the reasons for such conclusions are, and whether it was necessary in the public interest to take the extreme step of prohibiting such FDCs, instead of restricting or regulating their manufacture and supply. In order that an analysis be made in greater depth, we, therefore, feel that these cases should go to the DTAB and/or a Sub-Committee formed by the DTAB for the purpose of having a relook into these cases. It is important, however, that the DTAB/Sub-Committee appointed for this purpose will not only hear the petitioners/appellants before us, but that they also hear submissions from the All India Drugs Action Network.

“33. First and foremost in each case, the DTAB/Sub-Committee appointed by it must satisfy itself that the use of the Fixed Dose Combinations (FDC) in question is likely to involve any one of the aforesaid three things:

(a) that they are likely to involve any risk to human beings or animals; or

(b) that the said FDCs do not have the therapeutic value claimed or purported to be claimed for them; or

(c) that such FDCs contain ingredients and in such quantity for which there is no therapeutic justification.

“34. The DTAB/Sub-Committee must also apply its mind as to whether it is then necessary or expedient, in the larger public interest, to regulate, restrict or prohibit the manufacture, sale or distribution of such FDCs. In short, the DTAB/Sub-Committee must clearly indicate in its report:

(1) as to why, according to it, any one of the three factors indicated above is attracted;

(2) post such satisfaction, that in the larger public interest, it is necessary or expedient to (i) regulate, (ii) restrict, or (iii) prohibit the manufacture, sale or distribution of such FDCs.”

DTAB, incidentally, is the Drugs Technical Advisory Board.

Accordingly, the Sub-Committee re-examined the FDCs and gave a report prohibiting 15 of them. However, on September 8 this year, the Supreme Court gave relief to companies marketing these 15 types of combination medicines manufactured in India since before 1988. The Court said the technical advisory body’s report was not en­ough to ban them. The order effectively brings several popular cough syrups, painkillers and cold medication out of the ban. However, the apex court has also said that the government can still investigate the safety of these 15 drugs by initiating fresh investigations in case it wants to ban them.

FDCs are medicines with two or more therapeutic ingredients packed in a single dose. They are available in various forms such as tablets and syrups. Once combined, they become a new drug unless packed together without mixing them. Once they become a new drug, they require new trials and safety investigations. Once allowed to be marketed, any drug continues under surveillance for long-term safety effects and can be withdrawn any time if any violation is found by the regulator.

All these 15 drugs were under surveillance and the government has a mechanism where the side-effects of the drugs get reported. If these FDCs were irrational or harmful, the government’s surveillance system should have shown that. The very fact that the government has not been able to show their adverse effects means they are presumed to be safe by the end-users, the doctors.

Even in the December 2017 judgment, the apex court had categorically held that the DTAB/Sub-Committee should satisfy itself that the FDCs are likely to involve risks to human beings or animals; do not have the therapeutic value claimed or purported to be clai­med for them; contain ingredients and in such quantity for which there is no therapeutic justification and that the regulation should be in the interest of the larger public.

Doctors have been using these drugs since 1988 and they are even available over the counter. Since 1988, the government had not objected to the manufacture and use of these drugs.

In the light of these varying judgments, many medical practitioners and the public are confused. The Court says you can market them, while the health ministry says these drugs should not be used. The medical practitioner is now in a dilemma whether to prescribe them as there is a legal battle between the Sub-Committee and the apex court. If upon prescribing, the said FDC drug puts the health of the patient in danger, the medical practitioner will be held responsible. But who will be responsible if the pati­ent buys them himself and endangers his life?

—The writer is President, Heart Care Foundation of India and former National President, IMA