ET was the first to report on the expected shortage of the drug in its edition of April 6 and followed up with a report on June 11. Prices of anti-tetanus immunoglobulin drugs have also been increased on a review petition of vaccine maker Serum Institute of India.
The NPPA invoked its extraordinary powers under Para 19 of the Drug Price Control Order (DPCO), 2013 — a rarely used provision that allows the regulator to act in public interest to revise ceiling prices of four formulations-Carboplatin 10mg/ml Injection, Cisplatin 1mg/ml Injection and Anti-Tetanus Immunoglobulin in both 250IU and 500IU strengths.
The regulator had received applications from manufacturers seeking price relief for 82 formulations in all. Of these, a committee set up to examine the proposals recommended the upward revision of only these four while deferring the remaining 78 for want of additional information.
Carboplatin and cisplatin are critical drugs used for cancer chemotherapy and are used to treat a wide range of cancers including ovarian, lung, bladder and testicular cancers.
Concerns over their availability had been raised on multiple platforms in recent months with manufacturers warning that rising active pharmaceutical ingredient (API) costs driven largely by surging platinum group metal prices had made production increasingly unviable at regulated ceiling prices.
The NPPA had also held meetings with manufacturers to address supply concerns and ensure continued availability of the drugs in the market.In its deliberations, the authority noted that these formulations have been under repeated price control are generally used as first-line treatment and are critical to addressing the country’s public health needs. It observed that while its mandate is to ensure drugs remain affordable, access to life-saving medicines cannot be compromised. “Unviability of these formulations should not lead to a situation where these drugs become unavailable in the market and the public is forced to switch to expensive alternatives,” the authority noted.
The 50% one-time price increase on the prevailing ceiling prices for carboplatin and cisplatin will be reviewed after six months or earlier if warranted, given the wide fluctuation in API prices.
For the anti-tetanus immunoglobulin formulations the 50% increase has been granted as a comprehensive measure taking into account all relevant factors including market structure and supply conditions. The NPPA clarified that no separate adjustment on account of monopoly reduction would be warranted in that case.
The anti-tetanus immunoglobulin price revision also factors in a review order passed by the NPPA.