NPPA’s remark on FDCs faces strong objection from industrialists

• NPPA has cited problems in approving of the FDCs, saying it can cause over-medication
• It says that it might lead to higher prices fixed by private drug firms.
• Pharmaceutical industrialists argue that this decision falls beyond the jurisdiction of NPPA.

THD NewsDesk, New Delhi: Recently, at its 80th meeting, the National Pharmaceuticals Pricing Authority said that the retail price applications of new drugs majorly include Fixed Dose Combinations (FDCs) of two or more drugs. The NPPA raised concerns over the approval of these FDCs, saying that it may result in over-medication. Moreover, it also expressed its reservations against fixing the retail price of these FDCs. The authority said this might lead to a surge in prices if private pharmaceutical companies keep a price higher than the sum of their components’ cost.

This decision got the NPPA into heated debates with experts from the pharmaceutical industry.

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 following 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 accommodating 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 in the healthcare sector, opined, “All approved FDCs are subjected to safety and efficacy scrutiny before 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 the understanding and knowledgeable medical doctors providing underlying guidance concerning the selection of products for price control /price fixation and the like.”

The industrialists contended that this decision is not for the NPPA to take as it falls beyond their jurisdiction. They alleged that this infringes on the power bestowed on the DCGI, the only authority entitled to have a say in this matter.

Meanwhile, NPPA is still adamant about its decision to take this matter to the ICMR. According to NPPA, these FDCs’ guidelines believe that procedures regulating the dosage of these FDCs need to be reconsidered. Whether FDCs will be included in the NLEM 2020 or not remains a matter of contention.

Source: Express Pharma