Meril Life Sciences has asked for an exemption for its first locally made biodegradable cardiac scaffold, a naturally dissolving stent that clears blockages in arteries.

The National Pharmaceutical Pricing Authority (NPPA) in a meeting on 21 February has referred the matter to an overarching expert committee headed by the director-general of Indian Council of Medical Research to see if the product has any therapeutic advantage to merit a price exemption.

The exemption, if granted, will be valid for five years.

Meril Life is trying to seek an exemption under para 32 of the Drug Price Control Orders (DPCO).

“32. Non–application of the provisions of this order in certain cases: The provisions of this order shall not apply to, -

1. a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and not produced elsewhere, if developed through indigenous Research and Development, for a period of five years from the date of commencement of its commercial production in the country.
2. a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development 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.

    iii. a manufacturer producing a new drug involving a new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India:

Provided that the provision of this paragraph shall apply only when a document showing approval of such new drugs from Drugs Controller General (India) is produced before the Government.

Explanation: Notwithstanding anything contained in this Order, for the purpose of this paragraph “new drug” shall have the same meaning as is assigned to under rule 122E of the Drugs and Cosmetics Rules, 1945;  

Clearly, they are using the 32.1 clause for the exemption which says, “the price cap won’t apply if a new drug developed through a unique and indigenous process is patented under the Indian Patents Act and is not produced elsewhere”.

An earlier multi-disciplinary committee of experts met on February 7 and found that the product is eligible for exemption. The pricing regulator referred the applications to the Standing National Committee on Medicines.

Evidence shows that polymer stents are not better than the regular drug-eluting stents (DES).

The polymeric everolimus-eluting BVS (Absorb) was non inferior to the cobalt-chromium everolimus-eluting stent (Xience) for target lesion failure in the Absorb IV trial.

In the recently reported BIO-RESORT trial, further follow-up of patients who got the “Orsiro and Synergy biodegradable polymer-coated drug-eluting stents” continued to show no benefit over a traditional durable DES, according to the BIO-RESORT trialists. At 3 years, when the Orsiro should have completely lost its biodegradable coating, target vessel failure (combined cardiac death, target vessel-related MI, and clinically-driven target vessel revascularization) reached 10.0%, 8.8%, and 8.5% of those randomized to the Resolute Integrity, Synergy and Orsiro stents, respectively, with no significant differences between groups in this primary endpoint or its components.

If this stent is approved and introduced in the market, it should only be used with the informed consent of the patient.

An unnamed source said, “International data has shown that polymer stents are not better than the regular DES. The cost of the polymeric stent is exorbitant. We too had invested a large amount of money to develop a polymeric stent, but aborted the plan after information that this technology has been withdrawn from the international market. This is an innovation that does not bring any added benefit to the patient.”

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA