DoP sets up high level panel to assist on pricing, launch of new drugs
Department of pharmaceuticals has clearly defined the terms of reference for the committee, citing that the new committee be entrusted to deliberate and recommend its opinion on the claims of pharma industry
The department of pharmaceuticals (DoP) has set up a high-level committee comprising experts to assist on matters of pricing and launch of new drugs to help resolve issues in a time-bound manner.
The committee, which will include experts from India’s pricing regulator National Pharmaceutical Pricing Authority (NPPA), scientists, department of health research under the ministry of health and family welfare, representatives from drug regulator’s office the Central Drugs Standard Control Organisation (CDSCO), among others, will work on issues between the industry and the government.
“In view of the experience gained from implementation of Drugs (Prices control) order 2013, it has been decided to constitute a single multi-disciplinary committee of experts for consultation on all technical issues related to pricing, launch of new drugs etc where more clarity may be required and opine on matters referred to it by NPPA on discharge of its functions,” reads the order posted on DoP’s website.
There are two existing expert committees—a standing committee whose role is restricted to new drug launch and take decisions on how to implement price control; and another committee of experts that evaluates issues related to packaging and innovation.
The new multi-disciplinary committee constituted by the department will supersede the existing ones. “So there will be a single committee dealing with all of these issues and give its recommendations in a time-bound manner (four weeks),” said Malini Aisola from the All India Drugs Action Network (AIDAN).
DoP has clearly defined the terms of reference for the committee, citing that the new committee will be entrusted to deliberate and recommend its opinion on the claims of pharma industry about additional therapeutic features associated with any formulation and recommend separate ceiling price of scheduled formulation or retail price of a new drug with specified therapeutic rationale.
The committee has also been mandated to express its opinion about pharma industry’s claims about the novelty associated with relevant active pharmaceutical ingredient (API) formulations and give its opinion on exemption. The committee will have to give its decision within four weeks.
In the past the National Pharmaceuticals Pricing Authority (NPPA) has been at loggerheads with the industry, with measures on pricing receiving a frosty reception from stent makers specially the international pharmaceutical companies. Earlier this year, NPPA had brought down the prices of life-saving cardiac stents down by more than 80% and capped the prices of knee implants by nearly 69%, besides several other medicines.
Even as many in the industry welcome the step, they are also viewing the order as “interference” from the department in NPPA’s work. “I think NPPA would view this as interference because it was already following certain systems that seemed to work,” said one of the industry experts on condition of anonymity.
Probir Das, chairman of industry lobby Ficci’s Medical Devices Forum and the Healthcare Federation of India’s Medical Technology Forum, said that considering the spate of “unfavourable” pricing decisions. “I sincerely hope that the DoP-appointed Committee looks at systemic improvements and not at myopic band-Aid solutions,” he said.
Adding that the recent decision on pricing did not demonstrate any benefit to the patients. “The price of angioplasties conducted in the private sector have not had a commensurate decrease to the stent price cuts, the number of angioplasty procedures in either private or government have not gone up due to price control, and the out-of-pocket patients have benefited less than the insured patients post price control. Hence stent price control has not had the desired effect on the increase of access among the underprivileged.
Frankly in India, access is limited by the small number of Cath labs and low number of interventional cardiologists”.
The pharma industry is also of the view that the decision has been taken following recent developments with the US. In September this year, the US trade representative (USTR) Robert E. Lighthizer wrote to commerce minister Suresh Prabhu and the prime minister’s principal secretary Nripendra Misra that the policy had created serious problems for US stent makers in India. He also urged India not to extend caps to other devices.
People privy to the matter say that the order was in the offing for a long time and not in response to the US government’s interventions. “This will bring uniformity and help avoiding confusions between the industry and the Government,” said a person privy to development.
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