NPPA Asks Cos To Ensure Critical Drugs Are Available

Mumbai, 13 Nov 2019:

 

Keeping in mind patient interest, drug prices regulator National Pharmaceutical Pricing Authority (NPPA) took a slew of decisions, including directing certain companies to ensure availability of critical medicines, and exempting a “novel” oncology formulation from price control.

 

The drug regulator asked companies including Abbott Healthcare, Bayer Zydus Pharma and Sanofi Synthelabo to not discontinue critical medicines for malaria, leprosy and anti-arrhythmic (cardiac) without prior notice to prevent their shortages in the country.

 

The companies had sought approval to discontinue manufacture/marketing of these medicines — Abbott Healthcare had approached for leprosy drug Hansepran, Bayer Zydus Pharma for malaria medication Resochin, and Sanofi Synthelabo for cardiac medicine Adenocor, sources told TOI. Fearing that a sudden discontinuation could lead to drug shortages, NPPA has asked these companies to issue a public notice, and continue production/import/sale for 12 months after that.

 

In the case of Hansepran, in which Abbott has around 98% market share, the regulator has asked the department of pharmaceuticals to invoke a Drug Price Control Order (DPCO), 2013 provision that empowers the government to issue directions to manufacturers for regulating distribution of drugs, in case of emergency, or in case of non-commercial use in public interest with a view to achieve its adequate availability.

 

If the company applies for upward price revision, it shall be considered according to modalities by the standing committee on affordable medicines and health products, NPPA said. When contacted, an Abbott spokesperson said, “The company had applied for discontinuation of Hansepran 50mg and 100mg (Clofazimine Capsule IP 50 and 100mg) due to unavailability of the active pharmaceutical ingredient (API) in India, and increased costs from the alternate supplier outside of India. We are waiting for NPPA’s response to our application.”

 

A Sanofi spokesperson said the decision to discontinue cardiac drug Adenocor has “nothing to do with pricing, and is part of our regular review” of therapeutic portfolios. “Sufficient appropriate and alternative medicines are available in the country, while for the company, overall commercial opportunity is small”.

 

In another major development, NPPA exempted Sun Pharmaceutical’s “novel’’ oncology injection, gemcitabine hydrochloride from price control, while it deferred a decision on cardiac stents (MeRes100) by Meril Life Sciences, due to safety concerns. In its meeting on October 30, the regulator exempted Sun Pharma’s ready-to-use infusion bags of gemcitabine hydrochloride from price control, as it is helpful in administration to patients.

 

Both companies had filed for price exemption on their drugs under para 32 (ii) of DPCO, 2013. Under this, NPPA can exempt drugs from price control which are either new or have a new delivery system that is developed through indigenous research, or have a process patent.

 

At present, gemcitabine hydrochloride is available in the powder form, and has to be reconstituted. The company will soon launch the ready-to-administer injection in India. Sun Pharma’s oncology injection is premixed in a sterile environment and supplied in ready-to-administer bags, preventing problems of over or under-dosing, and risk of contamination. The Standing National Committee on Medicines noted there is no clinical study to suggest that the company’s oncology injection offers significant therapeutic advantage.

 

Further, NPPA decided to defer a decision on Meril’s bioresorbable vascular scaffold system, MeRes100 which dissolves naturally in the body, in the wake of safety concerns raised by NGO, All India Drugs Action Network. The issue has been referred to drugs controller general and ministry of health and family welfare. The Times Of India