The medical device market is probably one of the most complex and challenging business segment in the pharmaceutical industry. With the advance of science and technology, the range of products offered as medical devices along with their sophistication have increased manifolds. Quality, safety and efficacy of these products should be comparable with that of drugs, as the use of defective devices can lead to serious complications and infections in patients.
The demand and growth potential in the medical device segment is phenomenal. India is one of the fastest growing medical device market, which is estimated at around Rs 5750 crore with a predicted annual double digit growth rate of 23 per cent or more for the coming years. The market size for medical devices in India is expected to touch US $1.7 billion by 2010, up from US $1.4 billion presently. Out of the total estimated turnover, diagnostic equipment account for about Rs 2000 crore, market for surgical equipment stand at Rs 1300 crore, imaging devices account for Rs 1300 crore and electronic treatment devices generate a business of Rs 1000 crore.
The trends clearly indicate that the penetration levels are higher in the country due to better affordability by patients, increased awareness and improved hospital infrastructure. The demand for high-tech products constitutes closer to 80 per cent of the overall Indian market. Since domestic production comprises primarily of low-tech devices, nearly 90 per cent of the demand is being met by imports from countries like USA, Japan and Germany.
Challenges & Issues
Indian companies although manufacture a large variety of medical devices, face a number of challenge. Depending upon the stage of the product, these can be classified as pre marketing stage, placement on market and post marketing stage.
Pre marketing stage
Gaps exist throughout the product life cycle right from definition and classification to nomenclature of medical devices. Study reports and documents to be submitted as part of safety and efficacy data are arbitrarily defined. Apart from this, standards followed during testing and manufacturing like those for drugs (monographs) are not available. In fact, what is available is a large number of ISO standards for process/ product compliance.
Usually standards and specifications are generated during the design and development of a device by the manufacturer. Several Indian manufacturers exporting devices to other countries have adopted ISO 9001:2000, ISO 13485:1996 or ISO 13485:2003 to stick to quality by design concept and for internal regulation. But the majority of the manufacturers haven't yet embraced all these standards. Also quality systems followed and audit compliances leave much to be desired.
Placement on market
Manufacturers are confronted with problems like regulatory requirements, unheard registration charges, advertising and promotion issues, apart from lack of guidance on claims that can be laid down for the product.
Post marketing stage
There is a poor surveillance and monitoring system for medical devices in the country with product recall almost next to impossible. Besides, adverse event reporting format to befollowed and concepts like data bank linkage are in nascent stages.
India also imports a large variety of high end critical devices, super specialty devices, clinical sample analysis equipments and machineries, electronics and software controlled devices, in vitro diagnostic systems and kits from foreign suppliers, especially European countries. Although most of the imported devices claim to be manufactured as per international directives, several of them end up being defective.
Regulatory aspects
The Indian medical devices sector is marred by weak and flexible regulations. In several cases, even when there are potential new products, regulators do not have the capacity to assess their safety and efficacy due to lack of guidelines and expertise. Government has always followed a general liberalisation of trade and investment laws for medical devices, which includes provisions like exemption for life saving devices and reduction of tariffs on imports. In fact, most devices do not require an import license to enter the market. This led to an inundation of Indian market with all kinds of imported devices which are difficult to monitor. The main examples of these discrepancies include:
● In 2004, the Mashelkar Committee called for the creation of a specific medical devices division within the Central Drugs Standard Control Organisation (CDSCO) to address the management, approval, certification and quality assurance of medical devices
● Widespread news of loose regulatory controls exemplified by extensive illegal re-processing and repackaging of used syringes for resale.
● The loopholes in medical devices regulation became even more evident in 2005 with reports that the state run JJ hospital in Mumbai used unapproved drug eluting stents on as many as 60 high risk cardiac patients in 2004. The stents were manufactured by Occam, a Netherlands-based company and marketed under the brand name Axxion. Not approved for use in Netherlands, they were marketed in India by the Mumbai-based Shruti Medi Science.
This was followed by a widespread debate on the legal status of stents. Several experts excluded medical devices from the drug list as the Drugs & Cosmetics Act does not cover medical devices. Others felt that the name "drug" eluting stents itself categorised them as drugs
● In 2005, the Maharashtra FDA directed manufacturers and importers to obtain licence from drug controller general of India (DCGI) for all in vivo devices, especially drug coated stents
● In a landmark decision, the Bombay High Court on September 19, 2005 asked the Central government to fix standards for medical devices
The Ministry of Health and Family Welfare under Gazette notification S.O. 1468 (E) dated 06/10/2005 finalised a notification amending the D&C Rules to include medical devices. It declared the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the act:
● Cardiac stents
● Drug eluting stents
● Catheters
● Intra ocular lenses
● IV cannulae
● Bone cements
● Heart valves
● Scalp vein set
● Orthopaedic implants
● Internal prosthetic replacements
Changing regulatory scene
The regulations, expected to be effective from March 1, 2006, were shifted to June 29, 2006 for implementation. This gave a breath of fresh air to companies involved in the manufacture/marketing of medical devices to prepare themselves for the change. It was also notified vide GSR 627 (E) dated 07/10/2005 that control over manufacture of these devices would be exercised by DCGI, which will be the nodal body. The sub-committee constituted by the Drugs Consultative Committee (DCC) to formulate rules for licensing of the 10 devices notified as drugs, had to device a fresh set of regulations.
Manufacturers are now expected to submit all documents pertaining to the manufacturing details and product details of their product. Thus a prior approval has been made mandatory for importing as well as marketing devices in the country by foreign as well as local companies. Applicant of manufacturing license has to furnish details such as personal details, product information, regulatory status in other countries, drug master file (details of good manufacturing practices (GMP) employed by the manufacturer to ensure quality of the device), proposed post marketing surveillance programme and undertaking of conformity with respect to product standards, safety and effectiveness requirements, apart from quality systems in the country of origin. The importers, stockists and retail sellers of medical devices shall obtain appropriate sale license from the State Licensing Authorities for these Medical Devices within a period of three months from the issue of these guidelines.
The regulation, at a later stage, also aims at including in vitro medical devices. There is a provision for constituting special evaluation committees to regulate the quality of devices and ensure that the manufacturing facilities are GMP compliant.
Implications
Like new patents act, medical device regulation has also started a debate on whether it'll be a tool in furthering our device market or will hamper its growth. The new guidelines are seen by many as an effective tool meant for introducing order and regularity in the ever neglected medical device segment of the pharmaceutical industry. The directive also aims at instilling faith amongst patients and doctors towards devices being floated in the country. This will also help our industry at international levels as globally all medical devices undergo stringent quality norms.
But according to many, the picture is far from rosy with speculations that the new regulation may hit the Indian medical device sector in other ways. The biggest losers in all probability will be patients and small scale manufacturers. Poor patients may be deprived of cost effective but non FDA and non CE approved life saving devices. For instance, the inexpensive non-FDA and non-CE approved drug eluting stents (DES) is priced at around Rs 60,000, whereas the FDA and CE approved stents is priced at around Rs 100,000 and above.
The regulation may also charge India in terms of huge cost advantage in producing economic but effective devices leading to an overall amplification of price. The new stringent quality control measures on medical devices will leave only a few multinationals in the market. This could hit supply and availability of devices in the market. Indian companies will take time to upgrade their facilities and manufacturing as per the current standards, others who fail will perish. Apart from this, communicating these current events to all pharmaceutical manufacturers will be quiet a challenge for the regulatory agencies.
Another concern of manufacturers is that filings done according to the new requirements will require more data to support applications for the registration of products. Different data requirements require additional work, time and money on the part of the company delaying processes. There is a big question mark on the efficiency of the new medical device regulation authority and whether it will have the required man and material facilities to ensure effective regulation.
According to the new regulations, an applicant has to pay US $1,000 for each product that one wishes to register. The same also applies for imported products. Apart from this, every modification of the device that involves material or method of use, an extra US $1,000 for registration has to be paid. Many of the manufacturers have an objection to this as they specialise in making only a number of devices having a limited supply.
The guidelines given by CDSCO deal only with sterile medical devices that are comparatively less in numbers. On the other hand, the non-sterile ones have still been not regulated. The regulations also need to be upgraded each time newer high technology devices come up for registration.
Recommendations
A number of steps can be taken to ensure that the prime requisites and aims of the current regulations are achieved and efforts do not go in vain. These include:
● Centralised drug regulatory authority: It is essential to have a centralised control authority similar to US FDA with a clearly stated mission. It should be responsible for all activities related to devices such as manufacture, import, export, quality checking, certification and surveillance of devices
● Clearly defined provisions: The regulatory authority should lay down clear provisions and guidelines as to what should be the content of the dossier, how should the clinical trials be conducted and the conduct of GMP audits. There should be a clear definition and classification for different medical devices
● Constantly evolving regulation: The set of guidelines should be updated periodically in order to keep pace with the ever evolving technologies
● Making registration easy: The regulatory agency should make sure that the registration procedure is easy and manageable for the device companies by providing simple roadmaps for registration. The registration costs can also be revised by taking into consideration the limited devices market
● Studying foreign set ups: Well established regulatory frameworks of foreign countries such as the US FDA and CE registration in EU can be used as references, while fabricating a local set-up competent with international standards
● Fast track registration: It can be adopted for all devices that already have a US FDA certification or the CE mark cutting down the time and cost required for the devices to reach market. But it should be made sure that the device is marketed in the parent country
● Pharmacovigilance: Pharmacovigilance and post marketing surveillance should be made stringent making possible the recall a product if it is proved harmful in the marketing phase
● Creating awareness: Creating awareness among device companies can be achieved by making use of mass media to propagate the message such as newspapers, pharmacy magazines and newsletters, pamphlets and sending a copy of the regulation guidance document to companies involved in the production and marketing of devices. Awareness programmes for the general public can also be organised in order to educate them for using only certified devices. In case a device looses its registration abroad it should be communicated to the applicant here and its users
● Controlling products: The authority should create a database for approved medical devices and vendors to regularise the flow of devices in Indian market
● Harmonisation initiatives: Aligning with other harmonisation initiatives such as Global Harmonisation Task Force (GHTF) and Asian Harmonisation Working Party (AHWP) for making globally acceptable products can also be done. This reduces time and documentation and also results in an exchange of expertise between member states
Looking ahead
Although there are hassles in implementing the new regulations, the future seems bright for the Indian medical device market. As the new guidelines come into practice, there is expected to be a better collaboration between scientific disciplines and engineering technology to come up with better research and development initiatives resulting in finer products. The regulations will certainly build up confidence in the medical device industry and the international regulatory authorities towards maintaining safety, quality and efficacy of the devices manufactured, imported and exported.
(Dr Arun Garg is principal of Advanced Institute of Pharmacy, Haryana and Kirti Yadav is scientist with Kinapse Ltd)