The National Pharmaceutical Pricing Authority’s (NPPA) recently raised concerns over the approval of FDCs.
In the recently held 80th meeting of the NPPA, the authority mentioned that the retail price applications of new drugs mainly consist of Fixed Dose Combinations (FDCs) of two or more drugs. The NPPA expressed concerns that approval of these FDCs may compromise the rationale in the usage of the drugs and may lead to over medication. The authority also has apprehensions that fixing the retail price of these FDCs may lead to a higher price being fixed than the sum of the price of their individual components, resulting in profiteering by the companies.
The authority is of the view that guidelines in the usage of these FDCs need to be looked into. And accordingly, the authority requested that the matter may be highlighted to the Indian Council of Medical Research (ICMR).
However, this has not gone down well with many in the pharma industry. Some experts say that it is beyond their jurisdiction to look into the aspect of drug usage and also pointed out that it is questioning the given power to the DCGI, who is the concerned authority to deliberate on this subject.
Vivek Padgaonkar, Independent Healthcare Consultant, Former-Director OPPI( Project & Policy), Former GSK (Sales & Marketing) expressed, “Drug Controller General of India (DCGI) is responsible for approval of licenses, and fundamentally the function of NPPA is to implement and enforce the provisions of the Drugs (Prices Control) Order in accordance with the powers delegated to it. Though NPPA can render advice to the Central Government on changes/ revisions in the drug policy, it is beyond the jurisdiction of NPPA to view that guidelines in the usage of drugs approved by DCGI. In a way, it is questioning the DCGI’s power.”
Shirish Ghoge, Ex-senior Director Government Affairs of Abbott and Ex-senior Director of Public Policy and Government Affairs, Sanofi India, said, “FDC s are approved by the DCGI, based on the recommendations of clinical practitioners. They are very helpful for the administration of more than one drug to patients, especially those who have diabetes and cardiac problems. The DCGI and his team have done tremendous work to weed out irrational combinations. As such, the technical committee has no reason to worry about FDCs per se as their domain is pricing on the principles of pharmacoeconomics as per para 5(2)(1) of DPCO 2013.”
Dr Sanghavi, a practising clinician and a medico-marketing and techno-legal expert to healthcare sector opined, “All approved FDCs are subjected to safety and efficacy scrutiny prior to their availability. FDCs form the basis of facilitating optimal management of chronic ailments such as hypertension and diabetes.”
He added, “No one would willingly take three tablets or so for controlling blood pressure of blood sugar for long periods of life when a single pill FDC could have achieved the same result. The NPPA needs to strike a balance and a differentiation between ensuring affordable drugs for all ailments and making all available drugs affordable. It is a fine line but a well-defined differentiation, which regulators of this authority body can decipher if they have understanding and knowledgeable medical doctors providing underlying guidance with respect to selection of products for price control /price fixation and the like.”
It remains to be seen whether FDCs will find inclusion in the NLEM 2020.
It is sad to see the reactions of the pharma industry experts and taking shelter under the guise of “FDC s are approved by the DCGI, based on the recommendations of clinical practitioners”
Can these irrational FDCs ever be a part of Evidence Based Medicine.
Premium institutions like AIIMS, PGI-Chandigarh, SGPGI-Lucknow or NIMHANS-Bangalore do not approve these combinations. So are these recommendations of unqualified clinical practitioners called RMPs?
95% of these combinations are banned and license not granted even in neighbouring small countries like Bangladesh and Nepal.
Pharma industry should work on patient centricity rather than profit centricity
Vivek Hattangadi