NEW DELHI: India’s drug pricing regulator has raised a red flag against price exemption plea made by US drug maker Gilead Sciences for its medicine for treatment of chronic Hepatitis B, revealed NPPA in its minutes of the meeting.
Observing that the submission by Gilead was also tantamount to ever greening, which would mean a monopoly over patent term of the drug and as an effect pricing, the National Pharmaceutical Pricing Authority has sought clarifications from the company. Gilead had sought exemption from price control for its Tenofovir Alafenamide tablets (brand name Vemlidy) to capture a major chunk of Rs 140-crore market for chronic Hepatitis B in India.
Tenofovir Alafenamide is available under different brand names in India. Mylan sells it as Hepbest, Cipla as Tenvir, Zydus as Tenohep, Dr Reddys as Durataf, among others. According to the data available with Pharmatrac, sales of this product across companies stood at Rs 39. 2 crore for the 12-month period ending December 19.
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Opposing Gilead’s “multi-layered” plea seeking exemption from price control, NPPA in its minutes of the meeting dated January 20 revealed that Gilead had used three separate entities, one for seeking patent, another for approval of drug and a third for price exemption.
According to the price regulator, the application for exemption was filed by Gilead Sciences, which is a US-based company, and the patent granted by the Office of the Controller General of Patents, Designs and Trademarks to the same Gilead Sciences for Methoxy Phosphonate Nucleotide Prodrug. The drug controller granted permission to import finished formulation of Tenofovir Alafenamide 25 mg tablet to Gilead Sciences India, an Indian company, and the new drug is to be manufactured by Gilead Sciences, Ireland.
ET has reviewed the minutes of the meeting.
The Authority has asked the company to provide information about the relationship among the “three entities — Gilead Sciences (the patent holder), Gilead Sciences India (to whom import licence for the new drug has been granted) and Gilead Sciences, Ireland (manufacturer),” revealed the minutes.
“After receipt of details of relationship status from the company, further necessary examination would be undertaken regarding eligibility for exemption under para 32(i) of DPCO 2013,” observed NPPA.
The price regulator has also sought clarification from the Department of Pharmaceuticals (DoP) as to whether the foreign company, the applicant, the patent holder and the manufacturer can be treated as the same entity for the purpose of granting exemption from price control.
NPPA also observed that the application is for exemption from price fixation of Tenofovir Alafenamide tablet whereas the patent has been granted for “Methoxy Phosphonate Nucleotide Prodrug”. It has asked the patent office to expedite the same.
Gilead was granted patent in 2010 for a term of 20 years from July 2001. It is, however, unclear as to why Gilead took nine years to get clearance. An email sent to Gilead on Thursday did not elicit any response.
The company had sought exemption from price control for five years from the date of commencement of marketing of the product.
NPPA said the company has already given voluntary licence to many companies for manufacturing/marketing the products “Tenofovir Alafenamide 25 mg tablet” in India.
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