This article was also published on Medical Device Summit
The medical device market in India grew to $3 billion by the end of 2011. According to a recent report, that figure should more than triple over the next ten years, to reach $10 billion by 2022. While India’s market grows at this fast pace, its regulators are looking to overhaul how medical devices are registered and marketed in their country. While some new regulations passed in 2012, a more comprehensive bill may again be before the Indian Parliament in 2013.
Notified Medical Device Registration
Beginning this year, new regulations go into effect regarding the registration and re-registration of notified medical devices in India. For the most part, the process remains the same. However, minor differences include:
- Power of Attorney documents must now include medical device model and generic names and shelf life information. Current licenses must be amended before new models can enter India.
- Certificates must include both legal and manufacturing site names and addresses. They must also include product names, model names and generic names.
- Certificates that are submitted to the Drugs Controller General of India (DCGI) must be valid for six months or more following submission.
- Copies of Form 41 must now be submitted with applications for re-registering medical devices.
Clinical Trials Regulations
In 2012, the Central Drug Standard Control Organization (CDSCO) of India implemented a new series of regulations to improve clinical research supervision. More than 1,700 patients have died during Indian clinical trials in the last three years, and the new regulations were designed in large part to combat this.
As recently as January of this year, India’s Supreme Court declared that multinational clinical trials in India were creating “havoc.” In response to a Public Interest Litigation (PIL) filed against drug maker GlaxoSmithKline, the court ordered all clinical trials of new chemical formulations to be carried out in strict accordance with Schedule Y of the DCA. They further criticized the response of the CDSCO Deputy Drugs Controllers, and gave them until the end of January to refute allegations concerning lax oversight in clinical trials.
In the meantime, new clinical research regulations passed in 2012 include the mandatory reporting of all adverse events to the CDSCO within 14 days of their occurrence. In addition, organizations conducting clinical research must comply with new rules regulating compensation in the case of clinical trial injuries or deaths. They must make such information available in all patient consent forms, and they must report the same information to the proper licensing authorities.
Clinical trials must also be registered in the Clinical Trial Registry — India (CTRI) before the enrollment of any patients. CROs need to submit annual status reports on on-going, completed, or terminated trials, providing detailed explanations in the case of termination. Finally, all CROs must register ethics committees to ensure compliance with India’s Good Clinical Practice Guidelines for Clinical Trials.
The Clinical Establishment Act
Also in 2012, Parliament enacted the Clinical Establishment Act, which requires the registration of all public and private hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums and institutions that offer diagnosis, treatment or care for illnesses and injuries, among other functions.
The National Registry of Clinical Establishments was set to go out in August. In addition to categorizing all clinical establishments, it also establishes minimum standards for healthcare service.
PROPOSED REGULATION STILL PENDING
A proposed bill from India’s Ministry of Health (MOH) would — for the first time in India’s history — require the comprehensive regulation of all medical devices manufactured in or imported into India. Currently, there are no such regulations. Only 33 classes of medical devices are regulated, including cardiac stents, drug eluting stents, intraocular lenses, catheters and bone cement. Regulated medical devices are considered drugs under the country’s Drug and Cosmetics Act (DCA), and must be certified by the DCGI before they can be sold on the market.
The Drugs and Cosmetics Amendment Bill calls for the creation of a new category — medical devices – that would be regulated in accordance with a risk-based classification system. The bill would also give MOH the power to create new rules regulating medical devices. These could include everything from clinical trial rules to penalties for violation. The draft bill, which was proposed in 2007 and amended by Parliament from 2008 – 2010, has not yet been made available for public comment.
Nevertheless, it could bear some resemblance to a different bill proposed by the Department of Science and Technology (DST) in 2006. That bill — which has been tabled indefinitely — called for the creation of a Medical Devices Regulatory Authority (MDRA) with the power to issue regulations regarding the safety, performance, design and manufacturing of medical devices. In addition, the MDRA would have overseen a new, risk-based classification system for medical devices. That system may very well be resurrected in the new bill. According to the old proposal, medical devices would be divided into four classes:
- A (low risk devices such as thermometers and tongue depressors)
- B (low to moderate risk devices such as hypodermic needles)
- C (moderate to high risk devices like lung ventilators)
- D (high risk devices such as heart valves and implantable defibrillators)
If passed, the MOH bill will govern all medical devices in India, not just those currently regulated under the DCA. Foreign medical device companies wanting to manufacture products locally or import devices would have to comply with all manufacturing, design, labeling, packaging, import, sale use and disposal rules of the new legislation.
But the bill may take some time to pass. The old DST bill was never even presented to Parliament, after it became bogged down in opposition at the state level. Therefore, foreign medical device companies should have plenty of time to get their device registrations up to standard. One thing they will want to watch for, however, is new rules regarding clinical trials. If the bill is passed, some high-risk medical devices might require local clinical trials in addition to foreign clinical data.
Foreign medical device companies should be aware of current and future regulations that might affect their business in India. This includes the proposed Drugs and Cosmetics Amendment, which would completely overhaul all existing standards and lead to considerable cost increases for the registration and marketing of medical devices.
But while the evolving nature of medical device regulations complicates business for foreign medical device companies, opportunities for market entry abound. India’s rapidly expanding middle class will continue to demand better healthcare products and services, including medical devices. With the medical device market set to grow by 16 percent annually, foreign medical device companies that understand its dynamics will profit.