Drug regulator to Centre: Put heart valves, lenses on essential medicines list

Once a drug or medical device is included in NLEM, its price can be capped by National Pharmaceutical Pricing Authority (NPPA), which comes under Department of Pharmaceuticals (DOP).

Written by Deepak Patel | New Delhi | Published:July 31, 2017 3:53 am
Contact lenses, glucose level, glucose level testing, non-invasive glucose testing, C V Raman, raman scaterrig, human tears, fingerprick blood test, glucose testing, science, science news, indian express On March 31, the caps were increased by NPPA to Rs 7,400 and Rs 30,180, respectively, taking into account the latest wholesale price index (WPI). Representational Image

FIVE MONTHS after the Centre capped the prices of coronary stents, the central drug regulator has asked the government to consider including “heart valves, orthopaedic implants and intra ocular (eye) lenses” in the National List of Essential Medicines (NLEM) — such a move could bring these products under the purview of price caps. In a letter to the Union Health Ministry earlier this month, G N Singh, Drug Controller General of India (DCGI), said: “The Ministry of Health and Family Welfare (MoHFW) may constitute a separate committee for inclusion of heart valves, orthopaedic implants and intra ocular (eye) lenses in NLEM.”

As the DCGI, Singh also heads the Central Drugs Standard Control Organisation (CDSCO), which comes under the Health Ministry. The subject of Singh’s letter was: “Request for reducing the prices of surgical implants…” According to medical industry sources, Abbott and Edwards Lifesciences are among the largest companies selling heart valves in India while the top sellers of orthopaedic implants include Johnson & Johnson, Zimmer Biomet, Stryker, and Smith & Nephew. Alcon, a division of Novartis group, and Bausch & Lomb are the two big sellers of intra ocular lenses in the country.

Once a drug or medical device is included in NLEM, its price can be capped by National Pharmaceutical Pricing Authority (NPPA), which comes under Department of Pharmaceuticals (DOP). The DOP is run by the Ministry of Chemicals and Fertilizers. The prices of coronary stents were capped by the NPPA on February 13, with the ceiling price of bare metal stents fixed at Rs 7,260 per piece and that of drug-eluting and bioabsorbable stents at Rs 29,600 each.

On March 31, the caps were increased by NPPA to Rs 7,400 and Rs 30,180, respectively, taking into account the latest wholesale price index (WPI).

The trigger for the latest move appears to be a letter written by an Ambala Cantt-based NGO called Sahayata Sadan Samiti to the DOP on May 17, requesting that “surgical implants like heart valves, eye lenses, orthopaedic implants, knee implants etc.”, be included in the NLEM so that “common people can be benefited”.

The DOP sent this letter to the Union Health Ministry, which forwarded it to Singh for comments.

While suggesting the formation of a separate committee, Singh stated in the letter: “In this connection, it is mentioned that this (DCGI) office is responsible for quality, safety and efficacy of drugs and medical devices as per the provisions of Drug and Cosmetics Act, 1940, and Rules, 1945, thereunder.”

DCGI Singh and C K Mishra, secretary, Health Ministry, did not respond to queries from The Indian Express seeking comment. But a senior Health Ministry official confirmed receipt of Singh’s correspondence and said that the ministry is considering the suggestion and a decision would be taken soon.

In February, after analysing the margins or profit of various players involved in the coronary stents trade, the NPPA found that they were “exorbitant and irrational”, indicating “vulgar profiteering” by every player but mainly by hospitals.

While the average maximum margin for manufacturers on a commonly used drug-eluting stent was 27 per cent, the distributors and hospitals were earning an average maximum margin of 196 per cent and 654 per cent on it, respectively.

“The trade margins confirmed the general perception that the margins were exorbitant and irrational, indicating vulgar profiteering at every level and mostly at the level of hospitals, and that the existing trade channel had failed to eliminate the chances of unethical practices in the context of a traumatised patient suffering heart ailment and reaching a hospital,” the NPPA said in a detailed note attached with the minutes of the February 13 meeting where the stent price cap was decided.

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