Industry News



Industry News
Global Trends
Events Calendar
Web Links

Web Gallery

Advertising  Info



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 cancelled.

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

Soma Das
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...

Other News

DCGI Asks State DCs To Collect Data On Impact Of Revised Sch M Norms On SSIs
DoP Suggests Public Private Model For Development, Maintenance Of New NIPERs
Johnson & Johnson Net Up By 29.1% To US$ 4.5 Billion In Q1
BD Looking For New Growth Avenues In Emerging Markets, And India
Researchers Make Artificial Blood Vessels From Jatropha Bhavnagar’s CSMCRI Develops Biodegradable Polymer
Poly To Explore Global Medical Devices Market With Rs 100cr Investment
TTK Healthcare To Grow Medical Devices Biz, Enters Orthopaedic Implants Market With US Tie-up





Back | Back To Top | Previous | Next