Understanding the rising cost of active pharmaceutical ingredients (API) in the country and the industry’s dependency on China for API and its impact on certain essential medicines, the National Pharmaceutical Pricing Authority (NPPA) has recently announced a one-time price increase of 50 per cent for heparin injection for 1000IU and 5000IU/ ml. Although, it is a time-bound exercise for six months – until December 31, 2020, the industry observers are raising concern over short-term consideration of price revision and are in opinion that more drugs require similar consideration.
According to the AIOCD AWACS data, there are approximately 37 brands of different dosage forms and strength of heparin injection from 14 different manufacturers namely Abbott Healthcare, Biocon, Biological Evans, Celon Labs, Claris Healthcare, Fresenius Kabi, Fusion Healthcare, Gland Pharma, Samarth Lifesciences, Troikaa Pharmaceuticals, United Biotech, VHB Lifesciences and Veritas Healthcare.
In this regard, Shirish Ghoge, Ex-Senior Director – Public Policy and Government Affairs, Sanofi India, said, “It is strange to see the price increase granted only for six months and one does not understand the reasons why the NPPA departed from their practice of one year whenever DPCO para 19 in public interest was applied – whether for increase or reduction.”
Although, Dr Ketan R Patel, Chairman and Managing Director, Troikaa Pharmaceuticals felt satisfied and commented, “It’s a good decision. And we believe that the 50 per cent rise is quite substantial and a fair decision. In November, the government may review the situation and depending on the price of the API, take the decision to continue, decrease or increase the MRP.”
This move is in response to the several applications received by the NPPA from the companies involved in manufacturing/ marketing of heparin injection 1000IU/ ml and heparin injection, 5000IU/ ml, and having a major market share in the Indian pharmaceutical market. They expressed that due to the cost of APIs, which constitute a major portion of the input cost and which is mainly imported from China, has risen to a considerable extent, which is making the companies entirely unviable to continue to manufacture and market these formulations.
While giving a background to the situation, Dr Patel informed, “Subsequent to our representation, the government has taken a timely decision in the interest of the patients as well as the pharma industry.”
Besides this, the pharma companies involved in manufacturing of heparin injection have also contended that over the years, the regulated price has decreased whereas, there is a consistent increase in the price of imported APIs making it commercially unsustainable for the drug manufacturers to manufacture the said product. Therefore, the heparin injection manufacturers requested the NPPA for upward revision of ceiling prices of the injection by invoking under para 19 of DPCO 2013.
Ghoge said, “This increase is a welcome step and shows how NPPA has equal concern of availability of this life-saving anticoagulant drug, as they have for affordability. Moreover, it is a good balance to draw.”
Commenting on the price revision and questioning if it will increase the access to medicines, Vivek Padgaonkar, Independent Healthcare Consultant Ex -Director OPPI, Ex GSK said, “Industry experts believe that the DPCO 1995 was certainly not in line with the needs of a liberalised country and reasonably growing Indian pharma sector. The DPCO 1995 cost-based policy had certain limitations and resulted, in fact, into a negligible impact on patients/consumers while having an adverse impact on the ecosystem and industry. Further, the actual impact of the DPCO 1995 was not more than 20 per ce...
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