India still does not have a comprehensive set of rules for the manufacture and marketing of medical devices despite their increasing therapeutic use in human bodies for several years. The Central Drugs Standard Control Organisation (CDSCO) has been working on to frame specific standards for licensing of these products for more than 16 months now.

In the absence of a set of rules or any guidelines, the state drugs control authorities in the country are in total confusion with regard to the standards for licensing the 10 medical devices notified as drugs by the Central government in October 2005. The notified products are very much available in the market without license.

Senior drug control officials said that the authorities have failed to issue a single license for the notified products so far. Although some of the states have commenced inspection of storage and manufacturing premises as per the directive of a sub-committee under the CDSCO, the state authorities are groping in the dark on the standards and guidelines for issuing product license, they said.

Moreover, the Drugs Controller General of India (DCGI) has issued a circular to the state drugs controllers seeking information to take policy decisions on the issue after the October notification came into effect and the 60 day period allowed for manufacturers to submit application. The letter dated September 21, 2006 seeks information like number of applications received, the details of inspection carried out jointly with CDSCO, details of guidelines followed for such inspections and whether any experts were involved in the inspection.

"The aforesaid information is required in order to take policy decisions about the procedures, standard requirements to be adopted for grant licenses to medical devices," reveals the letter in possession with Pharmabiz. "This shows that the CDSCO itself is in confusion on the procedures to be taken. And it also reveals that the authority has not furnished any solid guidelines even after the period of implementation started from October 2006. Around 80 per cent of these notified products available in the markets at present doesn't have any approval but we cannot take action because of the DCGI's guidelines," said a drug control official from Andhra Pradesh.

"Currently the only guideline we have is Schedule M and we are inspecting the companies as per these norms. There is no other guideline with us specifically for medical devices licensing. There are a number of players in the segment, either as manufacturer or more as distributors and we are on the process of inspecting the sites," said a senior official from Gujarat FDA.

"We have sent the applications to the CDSCO and are conducting inspections in distribution and manufacturing centres according to their suggestion. But the details for licensing are yet to be cleared by the central authority. It seems that the central authority is on a deceleration in the issue," another official from Kerala Drug Control Administration informed.

Though product licensing is under purview of the state drugs control organization, the inspections are to be conducted in association with the CDSCO zonal officers. The CDSCO with strength of 40 officials for the entire country has to accompany the state officials in inspections simultaneously with its existing workload.

The CDSCO West zone has conducted inspection on around 35 units in January 2007, though the officials informed that not a single license for the notified products has been issued till date. The officials informed that only around eight units would pass through approval, while all the other applicants withdrew applications in a later stage.

The Drugs Consultative Committee (DCC), recently appointed a sub-committee consisting CDSCO officials and various state drugs control officers to set rules for licensing, according to sources. Currently, the Central Licensing Approval Authority (CLAA) is scrutinizing the applications and would suggest the state officials to carry inspection. The inspection reports will also be analysed by the committee for official nod, the sources said.

As Pharmabiz reported earlier, the Centre was forced to come up with a hasty notification on medical devices on October 7, 2006, following the directive of the division bench of Mumbai High Court to the DCGI on September 18, 2006 to notify sterile medical devices for external or internal use in human beings as drugs, with immediate effect. The 10 medical devices notified as drugs are, Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, I V Cannulae, Bone Cements, Heart Valves, Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic Replacements.

According to an official clarification, the notification was to be effective from March 1, 2006 under which a period of 60 days would be provided to the manufacturers and distributors to submit application for license. Later, period has been extended up to October 31, 2006 by the Union ministry of health.