Central Drugs Standard Control Organization
In another bid to give momentum to research and clinical trials in the country, the centre eased regulations governing the import and export of human biological samples for commercial purposes. The Directorate General of Foreign Trade issued a notification, August 4, saying that the import and export of such samples “should be permitted by Customs authorities at the port of entry / exit without prior approvals (import licence / export permit) from any other Government agency.”
As long as “the concerned Indian company/agency submits an undertaking that they are following and will follow all the applicable rules, regulations and procedures for safe transfer and disposal of the biological samples being imported/exported as per the related norms/regulations” to the Customs authority at the port of entry or exit, any other approval is no longer required. Prior to this change, such a company or agency had to submit an application to the Indian Council of Medical Research, which then made decisions case-by-case.
In 2011, ICMR had formed a committee of experts, chaired by the director general of the Council, to scrutinise and, only then, clear every sample going in and out of India. Among the documents that had to be submitted to the committee was a copy of the informed consent of the individual patient agreeing to their sample being used for a particular study.
The debate over the ethics of the commercial use of the biological samples has been around for over a decade now. A November 2002 article from the British Medical Journal notes the objection raised by Indian scientists to a genetic study done by British and German scientists on people from coastal Kerala. The article says the concern was that India’s diverse genetic information could be mined for commercial purposes without regulations.
This notification comes on the heels of two circulars issued by the Central Drugs Standard Control Organisation that also made getting approvals for and the logistics of clinical trials and research easier for companies. All three steps have been taken at the same time as the ICMR bringing out its draft National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, which set standards for ethical practices and consent, and safeguard participants.
One circular removed the cap of three trials per investigator. The other says that trial sites no longer need to have at least 50 beds. Both circulars hand over the decision making powers to the ethics committee presiding over each trial. It was also felt that since India has too few principal investigators, restricting them to only three trials at a time was not feasible.
The Union health ministry has issued the revised draft Medical Devices Rules 2016, introducing the ‘Quality Management System’ mandatory for notified medical devices and in-vitro diagnostics in lieu of the Schedule M which will now be applicable to pharmaceuticals products only.
As per the new Rule, the licensee of pharmaceutical products shall comply with the requirements of ‘Good Manufacturing Practices’ (GMP) as laid down in Schedule M and the licensee of medical devices and in-vitro diagnostics shall comply with the requirements of “Quality Management System” as laid down in Schedule M-III.
The provisions of this Schedule M-III shall be applicable to manufacturers of finished devices, in-vitro diagnostics, mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants intended for human or animal use.
The Schedule M-III specifies requirements for a quality management system that shall be used by the manufacturer for the design and development, manufacture, packaging, labeling, testing, installation and servicing of medical devices and in-vitro diagnostics. If the manufacturer does not carry out design and development activity, the same shall be recorded in the quality management system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions.
If any requirement in clause 7 (product realisation) of this Schedule is not applicable due to the nature of the medical device and in-vitro diagnostics for which the quality management system is applied, the manufacturer does not need to include such a requirement in its quality management system. The processes required by this Schedule, which are applicable to the medical device and in-vitro diagnostic devices, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer’s quality management system.
If a manufacturer engages in only some operations subject to the requirements of this part, and not in others, that manufacturer need only to comply with those requirements which are applicable to the operations in which it is engaged. It is emphasised that the quality management system requirements specified in this Schedule are in addition to complementary to technical requirements for products. Manufacturers of components or parts of finished devices and in-vitro diagnostics are encouraged to use appropriate provisions of this regulation as guidance.
The Official release of the DRAFT – Medical Device Rules can be found at LINK
Keen to diversify and meet the changing drug regulatory requirements in the country, the health ministry is soon set to revise the Drugs and Cosmetics Rules 1945. This strategic move is aimed at adopting progressive changes, while omitting unnecessary provisions from the rule book to bring in ease in regulations, enforcement and ensure better safety of patients.
To look into this matter, the Centre last week constituted ten separate committees each headed by senior members from the drug controller general’s office which includes joint drug controllers or deputy drug controller (DDCs) along with representatives from different state licensing authority, other government and industry stakeholders having expertise in the respective area. This committee will be responsible to deliberate and examine various provisions in the current rules and give their observation and suggestions on the changes needed in the rules either by amending the rules to include new ones as per current needs or omit the ones that have no importance in current regulatory context.
A highly placed source closely associated with this development informed that each group has been assigned as per key chapters in the rules. There is a group to study rules relating to good manufacturing practices (GMP) requirements; group to oversee sales and manufacturing of drugs; a separate group to examine import and export aspect; group to examine clinical trials and approval of new drugs; groups for studying rules relating to cosmetics; veterinary drugs; OTCs; biological drugs; stem cells and regenerative medicines and a group to examine phyto-pharmaceuticals.
“The current rules under the D&C Rules 1945, that are enforced through out the country is too outdated as they were drafted in pre independence era. Though amended several times, it definitely is high time to focus on revising the whole set of rules to meet our current challenges and regulatory compliance requirements. This will be a progressive step towards further strengthening the enforcement parameters which is key to ensure public health,” stated Dr H G Koshia commissioner of Gujarat FDCA. He is also part of the group set up for the examination of provisions relating to sale of drugs.
The Centre has finally released the much anticipated revised Schedule M-III notification that is aligned with IS/ISO 13485. Experts see this as a first concrete step towards adopting a separate medical device regulation in the country, an urgent need of the hour to safeguard the interest of the industry. There has been no specific regulation for medical devices and has been irrationally linked with pharma sector through common statute.
Revised Schedule M-III contains its own set of requirements for quality management systems pertaining to all notified medical devices and IVDs, plus appendices covering device master files and site master files. With this notification of Schedule M-III, the sector will now be able to explore new business opportunities as it will now open up for investments into R&D that will enable India to emerge as a world class-manufacturing hub for medical devices.
Rajiv Nath, forum coordinator of AIMED pointed out that this comes as a huge victory to that sector that was long struggling to have a foothold in this country due to lack of any government support leading to unfavourable market condition for the domestic players. He said that such neglect towards the sector had a detrimental impact on medical device industry making India import dependent.
Until now, Drugs & Cosmetics Act, 1940, governed the medical device sector, which has very different R&D, technologies, production and taxation requirements from that of phrama sector. Industry had been pushing for changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and international ISO 13485 standard for regulatory purposes.
Nath who is also the joint coordinator of the Indian Medical Devices Regulatory Review Group (IMDRRG) added that overseas and Indian investors were always apprehensive to invest in medical device sector since it had pharmaceutical type GMP demands imposed by regulators in an arbitrary manner. Experts stressed that the sector was always incorrectly and incompletely regulated by unsure inspectors.
“We are glad that the government has started taking strategic measures to address the issues and challenges of the industry. With the active support of the Centre we will sure be able to develop India as a manufacturing hub for medical device sector,” he added.
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Drugs and Cosmetics Act – Lesson 4 – Schedules Y
Rules and Permissions
122A – To Import New Drugs
122B – To Manufacture New Drugs
122D – To import or manufacture fixed dose combinations
122DA – To conduct clinical trials for new drug/investigational new drug
122DAA – Definition of Clinical Trial
122DD – Registration of Ethics Commitee
122E – Definition of New Drug
Appendices of Schedule Y
Appendix I. Data to be submitted along with the application to conduct clinical trial/import/manufacture of new drugs for marketing in the country
Appendix IA. Data to be submitted along with the application to conduct clinical trial/import/manufacture of new drugs already approved in the country
Appendix IB. Data to be submitted along with the application to conduct clinical trial or import or manufacture of a Phytopharmaceutical Drug in the Country
Appendix II. Structure, Contents and Format for Clinical Study Reports
Appendix III. Animal Toxicology (Non-Clinical Toxicology Studies)
Appendix IV. Animal Pharmacology
Appendix V. Informed Consent
Appendix VI. Fixed Dose Combinations (FDC)
Appendix VII. Undertaking by the Investigator.
Appendix VIII. Ethics Committee
Appendix IX. Stability testing of new drugs
Appendix X. Contents of the Proposed Protocol for Conducting Clinical Trials
Appendix XI. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial