Medical devices industry seeks more clarity on definition of manufacturer in draft New Drugs Bill, 2022
The domestic medical device industry suggested the definition of manufacturer need to be changed in New Drugs and medical devices and cosmetics Bill 2022 so that it cannot be misused in India context. AiMeD gives feedback to government on draft bill, in their observation the definition of manufacturer is not appropriate in Indian Context. The association requested the government that the definition of manufacturer should be, “Manufacturer is a person, an enterprise, or an entity who himself makes a product through a process involving raw materials, components, or subassemblies, usually on a large mass production scale with different operations divided among different workers….”.
A few more highlights of this update are:
Definition for accessories, abnormal use and clinical evaluation should be included in section 3 of the draft bill and software and accessory should be included in IVD.
They also suggested the government modify the bill as, investigational devices mean a device which is assessed in a clinical investigation, a systematic investigation involving one or more human/animal subject undertaken to assess the performance of the device.
For section 127 (d) association said that the colors should not only be used for brand and logo but also for the identification of size of medical devices.
For Section 128 (a), a Medical Device shall be deemed to be adulterated, “if it consists in whole or in part, of rusted or corroded or filthy or putrid or decomposed substance”. This definition of adulterated medical device does not fit well with the construction and nature of most of the medical devices which are engineered products made under a tolerance where the storage, usage conditions and usage skills need to be considered before putting a criminal insinuation on a manufacturer.
Medical device officer should not be a mirror copy of drug inspector under a different name.
The fees are for grant or renewal of license whereas as per Medical Device Rules 2017, there is no provision for renewal of license. The manufacturer has to pay fee for retention of license, it averred.
Here is brief of Draft bill 2022 news which was published couple of months before.
The ministry of health and family welfare released a draft of new drugs, medical devices and cosmetic bill 2022 to keep pace with changing needs, time and technology. The draft bill has been put up on the ministry’s website and recommendations, remarks and objections from the public and stakeholders have been sought within 45 days from the date of issue of the notice.
The aim of the draft is to replace the existing Drugs & Cosmetics acts 1940 to accommodate the changes and to adapt new technology. The Drugs & Cosmetics Act 1940 is pre-independence legislation enacted by central legislative assembly. The reason for replacement can be the review of obsolete legal guidelines and updation of the existing laws, which is a continuing process to accommodate changed requirements and adapt to new technology.” With the need to study obsolete laws and to “periodically repeal and amend laws.”
The important definitions mentioned in the draft bill:
The draft bill covers below important definitions:
- Clinical trials
- Over-the-counter drugs
- Medical devices
- Manufacturers
- Cosmetics
- Proprietary medicine
- New drugs
- Bioavailability studies,
- Investigational new drugs,
- Imported spurious drugs.
The bill introduces a separate definition for medical devices that includes all types of diagnostic equipment and their software. This bill will also include implants, devices for assistance with disabilities, instruments used for disinfection etc.
Changes for medical devices as per new draft bill:
This draft emphasizes the creation of a medical devices technical advisory board, which will include professionals and people with technical knowledge of the devices. The board will also include Officials from the Health Ministry, Department of Atomic Energy, Department of Science and Technology, Ministry of Electronics, DRDO, and experts in the field of biomedical technology, bio-materials, and polymer technology. Currently, the decisions regarding medical devices are taken by the ‘drugs technical advisory board’. This draft bill also proposes medical device testing centers along the lines of drug laboratories in states and at the central level.
As per draft the clinical trial or clinical investigations will need permission from central licensing authority, at present also companies seek permission from drug regulator to conduct trials which was not mentioned in previous law. If a person gets injured while performing a clinical trial, he will get medical compensation. The one who fails to provide the same will be punishable with imprisonment or a fine.
Apart from the medical devices this draft bill proposing changes in importing drugs and cosmetics, online pharmacies, provision relating to Ayurveda, Unani, Homeopathy drugs etc.
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References:
http://www.pharmabiz.com/NewsDetails.aspx?aid=153000&sid=1
