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MDC recommends against Cipla's plea for separate price for its asthma inhaler combination
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Gireesh Babu, New Delhi
September 27 , 2023
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The Multidisciplinary Committee (MDC) of Experts, that advises the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has recommended to close the matter related to special price fixation of Cipla's asthma inhaler drug combination as it did not find merit in the claim of the company.
The Committee gave out its recommendation on the long pending issue after placing a complete point-wise examination on the issues raised by the Mumbai-based drug major for separate pricing of its combination of formoterol fumarate dihydrate 6mcg + beclomethasone dipropionate IP 100 mcg inhaler (MDI).
The Committee observed that Cipla has failed to produce the separate license for its product and also did not apply to NPPA at any stage under Para 11 (3) for seeking separate price. The company also does not have published literature of their product, supporting the claims of improved efficacy over conventional products. The impact of the innovation on safety is also unknown, but simply extrapolated from the safety of the conventional product, from which the company claims significant modifications. The improved efficacy is also not apparent on the label of the product or through the license.
"The Committee deliberated in detail regarding the company not obtaining regulatory approval for the 'extra-fine particles of beclomethasone dipropionate and formoterol fumarate dihydrate' and the 'digital counter'. However, the request for differential pricing to NPPA used the same arguments. The Committee opined that this inconsistency in the approach of the company seemed deliberate, and was not in public interest," it said.
"In this context, the member from DCGI (Drug Controller General [India]) office mentioned that if the product is a special/separate product/an innovative product, the company should apply for a separate license and get its product approved from competent authority/regulator," said the Committee in its examination.
After considering various claims by the company and examining them, it said, "In view of the above, the Committee did not find any merit and recommended that the matter may be treated as closed."
The observation was made related to Cipla's submission that the approval or lack of it cannot be a factor for the Expert Committee to recommend the retail price. The observation of the Committee that the product has no separate license from DCGI as required for a new drug, is completely baseless and far from the truth. It also submitted that no new drug license is required for the product as the same composition is advanced owing to a smaller particle size.
Although the company claimed its product to be a superior product compared to the product of Lupin available in the market, Cipla had not made the patient and the licensing authorities aware about the same, such as through revisions in the product information leaflet, it added.
The company submitted that the particular formulation for treatment of bronchial asthma, where use of inhaled corticosteroid therapy found appropriate has been approved by the DCGI on January 5, 2011. From this, it is amply evident that as there is significant difference in terms of pharmacokinetics, pharmacodynamics, and efficacy-safety profile in two dosage forms of a medicine therefor, for the purposes of pricing, they ought to have been treated as differently and their respective prices should have been determined independently. Thus, the recommendation made by the expert committee is not only without any scientific basis, but is also in contravention of the principles and provisions of DPCO, 2013, it argued.
The Committee observed that the company requested for special price as their product is an innovation and claimed certain therapeutic advantages over the conventional inhaler. The product is an improved version, which will reach small airways owing to the reduced particle size. The company also claimed that the manufacturing process is highly complex compared to conventional formulation of the competitor, which is Lupin.
Responding to Cipla's submission that the MDC in its meeting held on July 31, 2019 had allotted a separate price to the product of Glenmark that had an integrated dose counter, but did not give separate price to Cipla inspite of having an integrated dose counter, the Committee said that Cipla had not applied for additional or separate price in their application dated February 7, 2019 and in its representation in May 17, 2019, which was deliberated and rejected in the 12th MDC meeting. However, the issue of additional price on account of digital dose counter was raised in the writ petition filed by the company in the High Court and in the review petition filed to the Department of Pharmaceuticals.
Further, the contention of the company that the cost of manufacturing is also different than the product of Lupin is not tenable as the prices are fixed as per provisions of DPCO, 2013 and National Pharmaceutical Pricing Policy, 2012 which mandates price fixation relies on market-based data, and not cost based data.
The matter was taken up in the latest MDC meeting held on September 15, after the NPPA asked the Committee to give it a clear recommendation on the matter and the Committee itself in a meeting in May, this year, decided to place complete point-wise examination.
The DoP in an order on October 3, 2022 on the review petition filed by the company, directed the Authority to consider Cipla’s application for fixing retail price of the drug under the brand Novello Inhaler, indicated in the regular treatment of asthma, for fresh orders on merits after analysis of the entire facts to avoid miscarriage of justice. The company has been in a legal battle including in the High Court for the last few years to get the retail price it demanded, considered and implemented.
Following the review order of the DoP, the MDC in a meeting held on December 2, 2022 recommended that Cipla’s application for special retail pricing for the combination drug may be considered for further examination, if the company submits published literature to demonstrate improved efficacy of its product and obtain the manufacturing permission/license from the licensing authorities along with the product label claim.
The dispute started after Cipla filed an application seeking retail price of Rs. 730 for 120 metered doses of formoterol fumarate dihydrate 6mcg + beclomethasone dipropionate IP 100 mg Inhaler (MDI), and the NPPA, in May 2019 published a draft working sheet recommending a retail price of Rs. 1.46 per dose for the product after considering the price to retailer of a competitor company. Cipla raised objections to the retail price in the draft working sheets, seeking opportunity to make personal representation.
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