DoP rejects review application by Win Medicare against NPPAs price fixation of hand rub product

New Delhi, November 17, 2022:

The Department of Pharmaceuticals (DoP) has rejected a review application filed by Delhi-based Win Medicare Pvt Ltd in connection with the price fixation by National Pharmaceutical Pricing Authority (NPPA) for its hand rub product.

The review application was filed by Win Medicare on December 21, 2020, against NPPA’s price notification on December 3, 2020 in respect of Betadine Alcoholic Hand Rub. The Multi-Disciplinary Committee (MDC) of experts, in a meeting held on August 28, recommended a price of Rs 92 for a pack of 200 ml considering the ceiling price of ethyl alcohol 50 per cent on the justification that data of Isopropyl Alcohol was not available.

The company filed its representation twice in September, before NPPA bringing out the alleged erroneous basis of price recommendation along with copies of invoices of ethyl and isopropyl alcohol. It also submitted the therapeutic advantages of using isopropyl alcohol over ethyl alcohol, following a query from the NPPA.

The company argued that the cost of isopropyl alcohol was substantially higher during the relevant period than that of Ethyl Alcohol and this was allegedly ignored by the MDC, in violation of norms of the Drugs (Prices Control) Order, 2013, and principles of natural justice. It also argued that once the drug is approved by the Drug Controller General (India) in a particular form, NPPA has no authority to alter or change the approved combination merely because the price of one of the ingredients of the approved combination is not available.

It also argued that the NPPA has allegedly no power under DPCO, 2013 to ignore the price of one of the approved ingredients of the combination and in its place take the price of another ingredient, which is not approved by DCGI. The company sought setting aside of the order fixing the price and for directing the NPPA to re-fix the retail price on the basis of considering the price of isopropyl alcohol instead of ethyl alcohol.

NPPA, on the other hand, said that the data of the subject formulation was not available in AIOCD-Pharmatrac, from where it sources the price details for price fixation. It said that the MDC, while recommending the price, took the ceiling price of ethyl alcohol (denatured) 70% since the price of isopropyl alcohol was not available.

Besides, the Authority invited Dr ArtiKapil, professor, department of microbiology, All India Institute of Medical Science (AIIMS) as a special invitee in the 24th meeting of the MDC held on November 11, 202. The expert observed that the efficacy of ethyl alcohol and isopropyl alcohol is similar when used as hand rub or skin disinfectant as per the international guidelines and recommendation on hand hygiene by CDC and World Health Organisation (WHO).

“Therefore, there is no justification or advantage of using one over the other,” she said. The matter was also discussed with other experts in infection control and microbiology at AIIMS and they also agreed with the view, she informed the MDC. There was no or negligible therapeutic efficacy in the usage of isopropyl alcohol over ethyl alcohol”, said the drug price regulator.

Examining arguments from both the parties, the Reviewing Authority of DoP observed that NPPA has its own mechanism of collecting the data from AIOCD-Pharmatrac and the company has not challenged unavailability of data on Pharmatrac.

“It is further noted that the matter was deliberated upon in detail by MDC of Experts in its four different meetings and after detailed deliberations and hearing the expert of AIIMS, it has concluded that the said ingredient has no/negligible therapeutic efficacy,” observed the Authority.

Further, it noted that while the applicant has referred to the product having been approved by the DCGI, the MDC of experts of NPPA, which recommended the price of the formulation, also had senior representatives of DCGI as its member.

“Based upon the examination and analysis of contention of both parties, the present review application is not sustainable and stands rejected,” said the order signed by Rajneesh Tingal, joint secretary to the Government of India, DoP.Pharmabiz