10% price hike cap on most medical devices
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
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