Owing to the supply chain disruptions and price hikes in raw materials of critical drugs, the National Pharmaceutical Pricing Authority (NPPA) on Friday relaxed its price control rules, and allowed pharma companies to substantially raise prices for a set of essential cancer drugs and vaccines, arguing that higher prices are necessary for their continued production and uninterrupted supply of these critical therapies.
Platinum-Based Chemotherapy
Through its extraordinary powers under Paragraph 19 of DPCO, 2013, NPPA allowed a one-time 50% increase in ceiling prices of two cancer drugs – Carboplatin, Cisplatin – citing sharp increase in API prices in recent years. In a notification, NPPA said that it had received applications for upward price revision for these two drugs due to increase in the cost of active pharmaceutical ingredients (APIs), production cost, and exchange rates. After examining these applications, NPPA noted that the prices of Carboplatin API and Cisplatin API have increased substantially in the recent years, adversely impacting the viability of production and supply of these formulations.
“The authority observed that uninterrupted availability of Carboplatin and Cisplatin formulations is critical for public health and patient care and that non-availability of such formulations may lead to disruption of treatment and compel patients to shift to costlier alternatives,” the notification said.
The revised ceiling prices of Carboplatin Injection 10 mg/ml and Cisplatin Injection 1 mg/ml have been fixed at Rs 90.74 per ml and Rs 10.89 per ml, respectively. The regulator also said the “in view of the wide fluctuations in raw material prices, the revised ceiling prices shall be reviewed after six months or earlier, as warranted”.
Immunoglobulins and Biologicals
In another order, NPPA granted a 50% one-time increase in the prices of anti-tetanus immunoglobulin injections, raising the ceiling price of the 250 IU vial to Rs 1,912.02 and the 500 IU vial to Rs 2,881.19. The decision follows a review application filed by Bharat Serums & Vaccines which is the sole domestic manufacturer of the product.
The company contended that the formulation has become financially unviable due to a significant increase in import-dependent API costs, fluctuations in exchange rates, and overall manufacturing expenses, resulting in persistent negative margins. A committee formed to examine Paragraph 19 cases noted that the formulation had remained under price control for years and that input costs had risen substantially. It further recommended price increase to ensure continued availability.
In a separate notification, the regulator addressed the issues raised by Serum Institute of India over the methodology used for fixing prices of certain vaccines. Previously, the company had challenged NPPA’s decision to apply a “monopoly reduction” while fixing prices of BCG, Measles-Rubella and Measles vaccines. It argued biologicals/vaccines can’t be compared with other products in the same therapeutic category because each vaccine is distinct in terms of manufacturing process, technology, and market dynamics.
The Department of Pharmaceuticals (DoP), while examining the review petition, observed that these specific vaccines are critical public-health products, have shown relatively stable price trends, and impose minimal financial burden on citizens. The department asked NPPA to reconsider the matter, citing an earlier precedent in the case of BCG vaccine where monopoly-related reductions had not been applied. Subsequently, NPPA allowed raising of ceiling price for all three vaccines by 20.6%.
Experts said that the latest NPPA notifications raise concerns over transparency. “While the regulator has explained the circumstances that warranted a revision in ceiling prices, it has not disclosed the underlying data or methodology used to arrive at the revised prices, particularly for vaccines and Anti-Tetanus Immunoglobulin. Public disclosure of the relevant cost and pricing data is important to maintain transparency in the decision-making,” said K.M. Gopakumar, Co-Convenor, Working Group on Access to Medicines and Treatment.