New Delhi: The Medical Device Rules were initially prepared with industry consultation, however the comments of the industry as well as certain elements where agreement was obtained between industry and Health Ministry officials were not incorporated in the draft that was published on October 17th, 2016 for stakeholder’s comments (within 30 days).
In a country where medical devices as an industry is in its infancy stage and the consumption in India is less than 2 percent of the total world’s consumption and where affordability and access are primary needs to cater to healthcare of millions of patients in India, the rules should be prepared for ease of access of medical devices by patients and not make it difficult. This was stated in the statement issued by the the Medical Technology Association of India on December 01. 2016.
MTaI has presented its recommendations to the government recently. The Industry is liaising with the Government and is hopeful that it’s submission of comments will be favourably considered by the Government of India. “In their current form the Medical Device Rules could severely jeopardize the continued supply of critical care medical devices to India. They will also endanger the huge investments made in Manufacturing in the country by global companies & will dent the FDI which has been growing multifold since it was sagaciously brought on the automatic route by the current government. Having said that, we are engaged with the Health Ministry as well as the CDSCO on the Rules, and if the past is anything to go by, their inclusive approach and nuanced understanding of the issues will help us once again reach solutions so that the supply of critical care devices will continue uninterrupted to the Indian patient,” commented Pavan Choudary, Director General, Medical Technology Association of India (MTaI).
The following information highlights critical issues and the impact which it has on Medical Device business in India and how these rules will increase the cost of the medical devices and also the effect on the availability of the products in the country which will impact the healthcare delivery of the country.
- a) Labelling requirements shall be pre-printed on the innermost pack and on every other pack accompanying the device:
Globally, labelling is done on the shelf pack and recognising this and all other pros and cons the Government came up with GSR 690E dated 25th September 2014. However the new requirement similar to that of drugs will require that India specific production will have to be taken even when manufacturing lines are country agnostic, and this will increase the cost of medical devices and in most cases will lead to issues relating to availability of the products in India. This will affect the healthcare delivery in the country.
The recommendation from MTaI is that the labelling requirements should be printed/ stickered in the shelf pack and in every other outer packaging in line with GSR 690E dated September 2014.
- b) Physical manufacturers name and address and the manufacturing date/shelf life/Expiry date shall be pre-printed:
As mentioned above, the labelling requirements is not aligned with International regulatory requirement. There are India specific requirements which has been included and there should be provisions to sticker India specific requirements on the shelf pack. Approval to this effect was given in the GSR 690 E. Japan and China also allows stickers pasting of country specific requirements. Mandating pre-printing the country specific requirements will lead to India specific production which will increase the cost of the device and in some cases will lead to issues on availability of the products in Indian market and this in turn will affect the healthcare delivery. MTaI recommends that the provisions in GSR 690E will have to be reinstated in the medical device rules.
- c) Shelf life of the medical devices shall not exceed more than 5 years:
Medical devices unlike drugs are more stable and hence restricting the shelf life of devices to 5 years will not be suitable for medical devices especially the devices made of stable metals. There has been claims from certain quarters that the restriction of shelf life is required for Indian conditions. The devices are available in India with 10 years shelf life for more than 20 years. From 2006 onwards the devices which were regulated were available in the country with 10 year shelf life. Hence there is no scientific data to backup such claims. However the manufacturers claim 10 years shelf life based on stability data. When devices are available with 10 years shelf life globally, there is no reason to restrict shelf life. Moreover, it is the duty of the Drug Law enforcing agency to ensure that only those storage spaces which can comply to the requirements of the law should be granted the licence to store medical devices. It cannot hide its inability, if any, to do so behind the argument that these are “Indian conditions” and therefore the shelf life granted should be less. It does not seek any such concession for drugs then why should it do so for devices.
The restriction of shelf life will lead to devices specially manufactured for India and that will increase cost as well as affect availability of the product in India .This will affect healthcare delivery in India.
- d) Provide Unique device identification of the medical device which shall contain device identifier and production identifier:
We welcome the incorporation of UDI barcodes on the product however it should be aligned with global implementation timelines. The European Union implementation time lines will be completed in 2027 and hence MTaI recommends that the implementation shall be in stages and that it should be aligned with European implementation timelines.
- e) Real time stability data and accelerated stability data need to be provided:
When newer technologies are introduced the device will be launched after completion of accelerated stability studies only. This is accepted practice globally. Hence mandating accelerated and real time stability data will hinder introduction of newer medical technologies. This will seriously affect the introduction of latest technologies. We recommend that either accelerated stability data or real time stability data shall suffice.
- f) Predicate device and the requirement for clinical trial:
MTaI recommends that medical devices approved by highly regulated countries like USA, Canada, Japan, Australia and European Union should be considered as predicate devices thereby waiving the clinical trial requirements before introducing the same in India. The DTAB in its 71st meeting has recommended that drugs approved by USFDA should be exempted from conducting clinical trials in India. This will pave way for early introduction of good medical technologies and will also reduce cost of the device.
- g) Plant registration copy need to be submitted for registration:
The concept of plant registration is not available in EU and many other countries. Hence, industry demands that ISO 13485 shall be mandated instead of plant registration certificate. This will become show stopper in registration process if the requirement is strictly implemented. Our recommendation is ISO 13485 certification in place of Plant registration.
- h) Requirements of storage, distribution and sale licence:
The requirement of sale licence for drugs has been referred in medical device rules. In drugs there are different categories like schedule C and CI drugs etc and the requirements to store them differs, example, some require deep freezers where as others require refrigerators. The medical devices cannot be classified in the same category of drugs. Also the storage conditions and the sale conditions are different when compared to that of the drugs. Hence mandating the requirements of drugs on medical devices for storage distribution and sale will not be suitable. We recommend separate rules for storage, sale and distribution for medical devices should be made.
- i) Regulation of class A devices:
There is no clarity in regulating class A devices. The indigenously manufactured devices are not regulated in India whereas all imported medical devices are regulated. Our recommendation is that as a policy either all Class A medical devices should be regulated or all Class A medical devices should be kept out of ambit of regulation.
To summarise the medical device rules which has been drafted in the current form is not suitable for medical devices and the Industry had given approximately 150 comments which need to be incorporated to make it suitable for medical devices.