By Namini Wijedasa The National Medicines Regulatory Authority (NMRA) has started verifying prices directly with global pharmaceutical manufacturers whenever it notices significant discrepancies between the rates quoted for certain drugs by local suppliers (intermediaries) and their regional/domestic prices. The regulator is also expediting the approval of new registrations for suppliers and manufacturers to break the [...]

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NMRA’s new measures bring down medicinal drug prices

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By Namini Wijedasa

The National Medicines Regulatory Authority (NMRA) has started verifying prices directly with global pharmaceutical manufacturers whenever it notices significant discrepancies between the rates quoted for certain drugs by local suppliers (intermediaries) and their regional/domestic prices.

The regulator is also expediting the approval of new registrations for suppliers and manufacturers to break the “monopolies and oligopolies held by some companies over certain drugs,” said NMRA’s Chief Executive Officer Saveen Semage. Some applications had been stuck at the NMRA for extended periods of time. Accordingly, a local manufacturer is also now licensed to produce the papaverine hydrochloride injection that is administered to heart patients. The drug caught attention after the Health Ministry revealed it had been sold to the public health sector since 2018 at prices ranging from Rs. 34,000 to Rs. 76,500 per vial.

The local importer was Yaden International (Pvt) Ltd., which sourced the medicine from the Indian company Mercury Laboratories Ltd. When Yaden recently submitted a bid to supply a new consignment of papaverine, the excessive price was flagged by a thoracic surgeon in the technical evaluation committee. It was recommended that the tender be cancelled, leading the bidder to drop the price to Rs. 370 per vial—a decrease of 99.5163 percent from the rate of Rs. 76,500 (the highest) quoted in 2018. Similarly, promethazine oral solution, which is given to children to prevent allergies, was brought down from Rs. 1,200 a bottle to Rs. 150.

The NMRA is now employing a system of vetting prices according to its own internal references and regional prices. Where there is a significant gap between the prices quoted by the importer and these benchmarks, the regulator will write directly to the manufacturer for the CIF (cost, insurance and freight) price of the respective products, Dr. Semage said. In the past, a letter from the local agent signed by the manufacturer sufficed.

Some drug prices are high because the manufacturers incorporate the “promotion” price in the rate offered, it is learnt. This includes costs incurred when pushing the drugs via doctors. The NMRA says it will no longer allow this.

“We are trying to arrive at a median range in prices, without having vast discrepancies,” Dr. Semage explained, pointing out that drugs like rosuvastatin (taken for high cholesterol) can range from Rs. 20 per pill to Rs. 75.

“In the past one year, we have identified monopolies and issued additional registrations,” he reiterated. “This has caused prices to come down (owing to competition). A classic example is immunoglobulin, which was sold for US$ 390 per vial and reduced to US$ 98 by the same company.” The importer was ABC Pharma, and the difference was nearly Rs. 90,000 per vial.

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