Expert panel recommends action against Panacea Biotec for launching Easy Six vaccine without price approval from NPPA

New Delhi, March 11, 2023 :

The Multi Disciplinary Committee (MDC) of Experts which advises the National Pharmaceutical Pricing Authority (NPPA) has suggested that necessary action might be taken against vaccine maker Panacea Biotec Ltd, for launching its vaccine Easy Six without price approval of the Authority.

The Committee also directed the company to apply afresh under the Para 32 of the Drugs (Prices Control) Order, 2013 if it is looking for an exemption from price regulation for its new drug Easy Four Pol, as the exemption under the Para is not self-invocable and it need the individual company to apply for it.

For Easy Six, a combination of vaccines for paediatric use, the company had not applied for exemption under Para 32 and it was launched without the price approval of NPPA, it observed.

The decision comes on an application filed by the company for retail price fixation of the Easy Four POl, a purified diphtheria toxoid, purified tetanus toxoid, whole cell pertussis, haemophilus influenzae type B conjugate, inactivated poliomyelitis, trivalent vaccine at 0.5 ml dosage form for which the company owns patent.

The MDC initially raised questions over the application, since the price claimed was higher while the other similar vaccines, such as the Easy Four TT, Easy Five TT and Easy Six, from the same company are available at much lower price. In a meeting in January, the MDC directed to check whether the company has applied for retail price fixation of the other three vaccines and the details thereof. It has also directed the Authority that if the prices were not fixed, necessary action may be taken against it.

In response to this, the company stated that the submission of Form I for the price approval for Easy Four Pol was made inadvertently since the vaccine is covered under a patent dated March 30, 2016. Hence, it requested to ignore the application and consider the same under the exemption of pre approval of prices as per the Para 32 of the DPCO, 2013.

According to the Para 32 (ii) of DPCO, 2013, the provisions of the Order does not apply for a manufacturer producing a new drug in the country by a new process developed through indigenous R&D and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent), for a period of five years from the date of the commencement of its commercial production in the country.

It has also informed the Committee that it had obtained the price approval from the NPPA for Easy Four TT and it was notified by the Authority in December, 2018. Regarding Easy Five TT, it said that the vaccine was non-scheduled at the time of its launch and later when the ceiling price of the same was notified by the NPPA in 2017, the same was implemented by the company.

With regards to Easy Six, the company mentioned that it had filed an intimation regarding grant of patent for the product.

Noting the explanation of the company, the MDC directed that Panacea Biotec may apply afresh under Para 32 if the exemption is to be sought in respect of Easy Four Pol.

“The exemption under Para 32 is not self-invocable. After receding the application for exemption under Para 32, NPPA shall examine the same for further deliberations by MDC,” said the Committee. The vaccine is not covered under the Universal Immunisation Programme (UIP) and therefore, the retail price is to be fixed by the NPPA.

The MDC directed that necessary action may be taken for the vaccine Easy Six in respect of which no exemption was sought by the company under Para 32 from NPPA and the same was launched without price approval of the Authority.

Panacea Biotec claims that all these vaccines are the first in the world. Easy Four TT, is a vaccine used for immunisation among children against diphtheria, tetanus, pertussis, and haemophilus influenza type b and is sold at a maximum retail price (MRP) of Rs 620 per pre-filled syringe, according to online pharmacy stores, which offers them on a discount from the MRP. Easy Five TT, which is a five in one vaccine for paediatric use is to immunise children against diphtheria, haemophilus influenzae type b, Hepatitis-B, Pertussis and Tetanus and has an MRP of 456 per vial. Easy Six, used for immunisation of children against diphtheria, haemophilus influenzae type b, pertussis, tetanus, polio and hepatitis B, has an MRP of Rs 2,632 per pre-filled syringe of 0.5 ml, according to the online pharmacy store Tata 1 mg. PharmaBiz