Sealing the FDC Drugs Fate
This is one inevitable news which obviously the Indian pharmaceutical industry would not like to hear as it would bring a big blow to the industry. Over 6000 medicine brands of different pharma companies and nearly Rs 2500 crore to Rs 3,000 crore market is at the stake for just one order from the health ministry that is expected any time.
The decks for the health ministry order to ban the Fixed Dose Combination (FDCs) Drugs are cleared now with a sub-committee of the ministry’s Drug Technical Advisory Board recommending such a ban. The sub-committee headed by Dr Nilima Kshirsagar, chair in Clinical Pharmacology at Indian Council of Medical Research, has recommended to ban 343 of the 349 “irrational” FDCs that are potentially harmful to patients. It has been stated that FDCs should be banned as their safety was not established by the respective drug producers. The remaining six drugs, the subcommittee has recommended, should be restricted and regulated.
This issue had been pending since over the last two years when the government banned these drugs first following a declaration made by a committee headed by Prof C K Kokate, vice chancellor of KLE University, Belagavi. Kokate committee was constituted following concerns of experts about the safety of FDCs which had been flooding the market. They posed more danger since patients were selfmedicating many of those drugs.
However the entire matter took a legal turn when the industry challenged the government ban order in different high courts. Delhi Court quashed the order on the grounds that before issuing the ban order the government did not consult the statutory bodies established under the Drugs & Cosmetics Act 1940. The health ministry challenged the Delhi High Court order in the apex court. Dr Kshirsagar committee was appointed following the Supreme Court order asking the ministry to re-examine the issue through another expert committee.
The recently submitted report of the Kshirsagar committee has now come as a bombshell for the industry as it reconfirmed the ban with serious observations against FDCs. The committee said the FDCs expose patients to overuse risks and could result into adverse effects on human organs. It has also pointed out that most of the FDCs producing companies challenging the ban failed to generate safety and efficacy data. Now that two subsequent expert sub committees have given the similar recommendation the industry may not have any other choice but to accept it.
The pharma experts are raising more fundamental and valid points in this issue. They have pointed out that the FDCs have flourished in India as companies used them to escape government price control. Drug price control orders capped the prices of drugs having only one active pharmaceutical ingredient (API). Companies combined different drugs into one FDC, thus making a new product, bypassing the price control. Mixing of drugs into one does not necessarily enhances efficacy of the new FDC, but the mixing of two APIs could lead to a possible toxic combination affecting the human body. Hence it is essential to test the new FDCs produced by combining two or more drugs.
Thus, the more serious issue according to the experts is how these drugs got approved in the first place without clinical trials. It appears that the central government regulator is blaming the state regulators for giving approvals overstepping their jurisdiction as only the central government regulator can approve a new drug. If this is the reality, as claimed by some media then it is a very serious issue which needs a thorough investigation.
It is important that besides punishing the pharma producers by banning their FDCs, the governments should also enquire into its internal systems and take action against the insiders if they too are violating any rules. The internal systems need to be free of systemic errors and people bypassing the rules to prevent recurrences of such incidences having potential to harm the patients.