Industry Annoyed Over Delay In Renewal
Of Import Registration Licences By DCGI Office
Wednesday, April 14, 2010 08:00 IST
Suja Nair Shirodkar, Mumbai
The drug importers in the country are annoyed over what they
termed as 'the avoidable delay' in the process of renewal of import registration
licences by the office of the Drug Controller General of India (DCGI). The
entire process which should not normally take more than two or three months now
takes more than a year, for reasons best known to the authorities only.
According to sources in the industry, there is a lot of delay
in renewing the import registration by the DCGI office, adversely affecting the
business. For the renewal of import registration licences a fresh application of
registration certificate has to be made nine months before the expiry of the
existing certificate. Ideally, the DCGI's office is bound to take action on the
application within six weeks from the time they receive the application for
renewal of re-registration of import licences. However, there are complaints
that the importers are not getting the registration renewal even after one year
of putting up the application.
Import registration is the registration of the manufacturing
site of a foreign manufacturing unit and the products manufactured therein,
intended for import into India under the Drugs & Cosmetics Rules. All the
biological and non-biological drugs, including bulk drugs, finished
formulations, vaccines, critical diagnostic kits, syringes, needles, sutures,
catheters, medical devices and internal prosthetic implants fall under the
preview of the import registration.
The Form 10 is referred as an import license and it can be
obtained by any Indian agent/distributor/manufacturer having valid wholesale
drug license or manufacturing license. The Indian agent has to apply on Form 8
and Form 9 has to be issued by the company having valid Form 41. Form 10 is
valid up till the validity of Form 41 unless it is sooner suspended or
Though DCGI Dr Surinder Singh could not be contacted, sources
said that the main reason behind the delay is due to the shortage of qualified
staff in the DCGI office.
Medical Device Cos Want Export Council
Posted: Wednesday, Feb 24, 2010 at 2317 hrs IST
Updated: Wednesday, Feb 24, 2010 at 2317 hrs IST
The domestic medical devices industry has mooted the formation of a medical
export council on the lines of Pharmexcil (Pharma Export Council), a body under
the commerce ministry that represents the interest of pharma exporters.
In a letter to commerce and industry minister Anand Sharma,
the All India Medical Devices Industry (AIMED) has urged to set up a Medical
Export Promotion Council or expand the scope of Pharmexcil to include medical
devices and rename it to reflect its inclusive nature. Pharmexcil apart from
being the sole agency to issue registration-cum-membership certificate to pharma
exporters, advices the government on policy issues related to pharma exports on
behalf of the industry and ensures hassle-free passage for pharma exports by
coordinating with overseas stakeholders.
The industry is also lobbying for the imposition of a uniform
value added tax regime on medical devices across states to eliminate market
distortion and usher in a level playing ground, geographically speaking. “Some
states charge VAT on MRP and others on invoice value. The VAT should be charged
in a uniform manner only on the invoice value. With the introduction of the VAT,
central sales tax and other form of taxes charged on the sale, purchase or
movement of goods should be phased out,” said Rajiv Nath, JMD, Hindustan
Syringes and Medical Devices. The export-oriented medical devices industry
exposed to currency volatility also expects government to offer cheaper credit
for exporters. Himanshu Baid, MD, Poly Medicure said, “On lines of China and
other South East Asian countries, cheaper credit (Libor + 1 or 2%) should be
made available to exporters for them to remain competitive. Also, due to
currency volatility, the overseas clients are reluctant to enter into long-term
contract. The government should also look at tying rupee to a ‘band’, like China
so that rupee’s value attains stability and stays within that band. This would
help the exporters to work on a fixed price with retain their overseas customers
for a long time”.
The industry also hopes that the skewed duty structure which
offers incentives to imported devices vis-a-vis domestic manufacturing should be
corrected. “We hope the government abolishes List 37 that comprises 111 medical
and surgical instruments and appliances. In case of these products, the duty on
import of components is higher than imported finished devices. This marks a huge
loss for the indigenous industry and inhibits growth of Indian manufacturers.
For instance, importing blood collection tube...