Drugs no more

Even as the European Commission is in the throes of tightening rules for the approval of medical devices following a series of health scandals, a move that has hit a political deadlock, India, it seems to have realised the growing importance of regulation in this sector as momentum is building to introduce the new medical device bill in the Parliament. Reports indicate that the Health Ministry has sent a note proposing the new bill to the Cabinet Secretary for approval of the Union Cabinet.

The bill that would replace the earlier Drugs and Cosmetic Act is expected to lay down separate provisions for Medical Devices including a separate definition of them, their risk-based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc. This is in stark opposition to the scenario today wherein medical devices are treated as drugs. The situation is unlike in the US and EU which have separate pathways for medical devices and pharmaceuticals.

Righting a wrong?

It was in 2006 that the Ministry of Science and Technology proposed the Medical Devices Regulation Bill (MDRB) in order to put in place stringent laws related to medical devices and establish the Medical Device Regulatory Authority of India (MDRA). The proposal was aimed at establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India. However, the bill is pending legislative action since then. Prior to 2005, only medical devices such as disposable hypodermic syringes, tubal rings, condoms, metered dose inhalers, were required to be registered in India when the Ministry of Health and Family Welfare (MoHFW) further notified 10 sterile devices (“Notified Medical Devices”) to be considered as drugs and consequently regulated their import, sale and manufacture under Section 3(b) (iv) of the D&C Act. Thus, from time to time any device which is intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette is considered as a drug under the D&C Act.

Giving a background on how devices ended up as drugs under the earlier act, Ajay Pitre, Managing Director, Sushrut Adler Group, explains, “Both the regulators and the industry were overtaken by events that moved rather abruptly (in 2006) wherein the need to regulate with immediate effect was forced on the government and it chose to notify selected ‘Medical Devices’ as ‘Drugs’ as an expedient route. This was a fundamental mistake – a fact not only evident by studying the global understanding on this subject but also a realisation by our regulators as of date.” It is to be noted that even though the domestic industry has been struggling to get its feet on the ground, over 75 per cent of medical devices sold in India are imported. India is one of the top three emerging markets for international medical device companies with newer companies entering the market every year. The new bill would also increase compliance w.r.t design, manufacturing, packaging, labelling, import, sale, use, and disposal requirements for companies wishing to import devices into India or manufacture products locally while also expanding the list of products requiring registration.

Stressing on a special focus on internationally harmonised affordable regulations, Dr A Didar Singh, Secretary General, FICCI, says, “Post marketing surveillance and adverse event reporting could be a more optimum solution for monitoring safe and effective performance than doing clinical trials on products well established for usage and safety in other countries. This will not only ensure the quality of devices manufactured or imported into India as well as provide the required impetus for local manufacturers to export medical devices.”

Regulation in India when it comes to medical devices has been restricted to reviewing of documentation and certifications of ‘imported’ products leaving the domestic industry largely unregulated. The lack of clarity on the implementation of the regulation, the application of the inappropriate drug law and the non-uniformity of understanding of the industry at the Central and State regulator levels has led to some rather piquant situations, Pitre adds. Thus domestic companies have been left to fend for themselves, and some have been setting standards of excellence and even meeting regulatory requirements of other countries.

Chips in V Sashi Kumar, Managing Director, Phoenix Medical Systems, a company which has set its own standards high, at par with international standards with many of its products having qualified for the CE mark and been awarded US FDA 510k certification. “Safety and efficacious treatment are frequently sacrificed on the altar of cheapness. With other countries, including Brazil, Russia, China and Turkey, having established regulatory systems, this bill has come none too early in India. The importance of the bill resides in the need to safeguard the welfare of India’s large population while reducing malpractices and encouraging genuine manufacturers.” Even Sushrut-Adler’s recent acquisition by Smith and Nephew is a testament to the fact that such companies are at par with their international counterparts and better are recognised for their world class products. However, it is up to the regulators to empower indigenous manufacturers while creating a level playing field for all parties involved.

The way forward

In a final draft of the guidelines on medical devices, the Drug Technical Advisory Board (DTAB) recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market under Schedule M III of Drugs & Cosmetics Rules 1945 while classifying them into Class A, B, C & D as per their level and intended use. All such devices sold in India (except for custom made devices, meant for a particular patient use) should, as a general rule, bear the Indian Conformity Assessment Certificate mark (ICAC) to indicate their conformity with the provisions of this schedule. The new Bill is expected to bring all medical devices sold in India under the purview of the government agency charged with regulating medical devices: the Central Licensing Approval Authority (CLAA) under the CDSCO. For the moment, however, the CLAA only requires certain categories of devices that have been the subject of notifications in the Official Gazette of India (21 device categories in total) to register with the CDSCO. Apart from the notification issued in 2005, in March last year, the Government upon the recommendation of the DCGI and examination by the Expert Committee, has further confirmed 11 devices such as Spinal needle, Insulin syringes, three way stop cock as an accessory of I.V. Cannula/Catheter/Perfusion Set, Introducer sheath, Cochlear implant, Close wound drainage set, AV fistula needle, Extension line as an accessory of Infusion set, ANGO kit/PTCA/ Cath Lab kit, Measure volume set and Flow regulator as an accessory of Infusion set as drugs.

FICCI recommends a single regulatory authority with sufficient resources allocated to it for effective implementation and monitoring of the regulatory framework alongwith a thorough and careful interlinking of various Govt Ministries/Departments (like CDSCO, MoH&FW, DEITY-MCIT, DoT-MCIT, BIS, DGFT, AERB and more) presently involved in Governance of Medical devices.

Elucidating the role of CDSCO and the future ahead, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) says, “ After the bill on Regulation of Medical Devices and Patient Safety is passed by a National Regulatory Authority under the Ministry of Health, the current CDSCO’s role could be enlarged with more autonomy and renamed as the Indian Healthcare Regulatory Authority with decentralized Divisions for Drugs, Cosmetics, Medical Devices and Diagnostics.”

He also advocates sharing of regulatory controls given the vast diversity of technologies and varying risk profile of Medical Devices with a National Regulator for Policy, Licensing & Registration of Manufacturers/Importers/Exporters for enabling a single window and harmonized controls; Utilization of CAB’s ( Conformity Assessment Bodies) for delegating the task of factory audits of Indian and Overseas Manufacturers for Compliance to Good Manufacturing Practices/ Quality Management Systems and the State Regulatory Authority for Licensing and Registration of Traders Distributors/Dealers/Warehousing Sub Contractors / Retailers etc for regulating Logistics and Sales. This would require minimal increase in employment by the Governemnt and is the Regulatory Model being used in Europe, Canada, Australia, New Zealand with even the US and Japan reviewing the same, he adds.

The regulatory agency needs to set up suitable and capable infrastructure and staffing with the qualifications, skills and capabilities appropriate to regulate devices that are primarily engineering products used in critical health related applications. “Extensive recruitment and internal training are no doubt necessary by the regulatory authorities to create an organisation that can suitably regulate the industry in an appropriate manner with the objective of creating a vibrant domestic industry that can hold its head high on the world stage and earn recognition for quality and innovation,” exhorts Pitre.

Singh strongly feels that due opportunity must be provided to stakeholders for commenting on the Bill and give inputs and suggestions on the same through a formal discussion mechanism.”To ensure availability of care for the patients, it is imperative that a suitable transition time be provided to import / manufacture medical devices & equipments in India. Moreover as the implementation of new set of regulations will take some time, industry seeks interim guidelines and implementation plan for the new guidelines from regulators till the new regulations are fully in place.”

As we await the bill and its ramifications, lets mull on what Serge Bernasconi, Chief Executive, Eucomed, the European medical technology industry association was quoted as saying on the current situation in the EU, “We need to address the weaknesses of this system to make it even safer for patients without delaying access to safe, life-saving medical devices and without stifling innovation.” Perhaps this is the way forward for India as well.

shalini.g@expressindia.com