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10% price hike cap on most medical devices

The prices of all medical devices except for stents, condoms and intrauterine devices can only be raised by up to 10% in a year, the National Pharmaceutical Pricing Authority (NPPA) said in a new office order on Friday.

The drug price regulator also clarified that all medical devices notified as drugs under the Drugs and Cosmetics Act, including stents, orthopaedic implants, catheters and intra-ocular lenses, will have to mandatorily carry their maximum retail price (MRP) on their packs.

While the government has notified 22 medical devices as drugs under the Act, the prices of stents, condoms and intrauterine devices are capped by the NPPA directly, and companies manufacturing or selling these products have to take permission from the regulator before implementing any hike. However, for other 'non-scheduled' products, the regulator has allowed an annual increase of 10% in prices. For any hike beyond the limit, companies will have to seek permission from the regulator. Cautioning companies against overcharging consumers, the regulator said it was closely monitoring prices of not only scheduled but also non-scheduled products, and any violation would attract severe action and penalty under the Essential Commodities Act.

Several leading hospitals have already come under the NPPA's scanner for allegedly overcharging.

CDSCO to go online for all services in six months

The Central Drugs Standard Control Organisation (CDSCO) is set to become paperless within six months with completely shifting its services to online portal Sugam. The agency digitized 60-70 per cent of its services through Sugam portal so far.

In another six months we are planning to go completely electronic for all our services by doing away with requirement of any physical documents, said a senior CDSCO official.

With the launch of Sugam on November 14, 2015, firms can apply online for grant of registration certificates for import of drugs or import license of drugs in Form 10, under D&C Rules. They can also file online applications with respect to import registration and license of medical devices. Online submission has also been started for grant of approval to conduct bioequivalence studies for export purposes.

The main aim of this e-governance drive is to bring in transparency, accountability and competency in CDSCO which allows creating a real time platform and improve the safety and security programmes taken up by it.

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