|Year : 2019 | Volume
| Issue : 1 | Page : 31-33
Indian regulatory update April–October 2018
Amita Bhave1, Lakhvinder Singh Batolar2
1 Head Regulatory Affairs, Global Drug Development India, Novartis Healthcare Private Ltd., Mumbai, Maharashtra, India
2 General Regulator Affairs Manager, Johnson and Johnson Private Limited, Mumbai, Maharashtra, India
|Date of Web Publication||24-Jan-2019|
Novartis Healthcare Private Limited, Inspire BKC, Part of 601 and 701, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
This document provides updates in regulatory requirements regarding conduct of clinical trials in India.
Keywords: Central Drugs Standard Control Organization (CDSCO), D & C Rules, Drugs and Cosmetic Rules, Drugs Controller General of India, DCGI, gazettes, mendments, notice, order, regulations, revision, updates Central drugs standard control organisation, circular, drugs and cosmetic rules, drugs controller general of India, gazette, notice, order, regulatory updates, update
|How to cite this article:|
Bhave A, Batolar LS. Indian regulatory update April–October 2018. Perspect Clin Res 2019;10:31-3
| Draft Guidance Document on Bioavailability/bioequivalence no Objection Certificate (NOC) for Export Purpose|| |
- Draft guidance document was issued by the Central Drugs Standard Control Organization (CDSCO) for application/approval of BA/BE (Bioavailability/Bioequivalence) studies in Indian subjects for export purpose as per the Schedule Y and Test License in Form 11 of the Drugs and Cosmetics Rules, 1945. The said 27-page document contained Table of Contents for Sr. No. A to J.
- There are a large number of applications filed to the office of DCG(I) at CDSCO (head quarter [HQ]) requesting for approval to carry out BE studies for export purpose. Hence, for easy processing of such applications and to bring uniformity in decision-making, DCGI office intends to bring uniformity of documents submitted for review/approval, and hence, the above-mentioned draft guidance document was released. The concerned stakeholders were requested to submit their comments/suggestions on or before March 5, 2018.
| Office Order Regarding Public Relation Office E-mail ID|| |
- An office order was released dated April 23, 2018, regarding Public Relation Office (PRO). PRO office was set up earlier by CDSCO vide order dated March 7, 2018.
- Vide the above-mentioned office order, it was announced that E-mail ID has been created firstname.lastname@example.org to make the system more convenient and approachable to all stakeholders.
- The stakeholders can now forward their queries, grievances, and suggestions on this E-mail ID to PRO office.
| Notice Regarding Development of Ethics Committee Registration on Online Sugam Portal|| |
- A notice was issued by the CDSCO dated August 1, 2018, regarding SUGAM.
- Vide this notice, applicants were notified that applications pertaining to registration and re-registration of Ethics Committees can be availed through online SUGAM portal, to reduce time and transaction cost.
- It is decided that effective September 1, 2018, no physical applications for registration and re-registration of Ethics Committees will be accepted thereafter and all applications shall be mandatorily filed on the SUGAM portal.
| Order Regarding Work Distribution at CDSCO (HQ)|| |
- An office order was issued by CDSCO dated August 16, 2018, assigning distribution of work to the Deputy Drugs Controller of India DDC (I) at CDSCO (HQ) subsequent to transfers/promotions.
- Accordingly, different CDSCO officials are allocated specific work areas such as Global Clinical Trials/International Cell, Serious Adverse Events (SAEs), fixed-dose combination, and medical devices.
| Notice on Draft Pharmacovigilance System Inspection Guideline|| |
- A notice was issued by CDSCO dated September 27, 2018 (File no. CDSCO/INS/PV/002/18-DCG(I), on the release of the Draft Pharmacovigilance System Inspection Guidelines.
- References were made to requirements of envisaging the GSR notification No. 287(E) dated March 8, 2016 on maintaining a pharmacovigilance system by all Market Authorization Holders (MAHs) for collection, processing and reporting of Adverse Drug Reactions (ADRs).
- References were also invited to Section 28.2 of Schedule-M which mandates that companies holding manufacturing licenses are supposed to submit forthwith the reports of serious ADRs resulting from the use of their drug products along with comments and documents to the concerned licensing authority.
- It was also reiterated that it is mandatory in Schedule-D (II) Section 2.18 that the importers of “drugs” shall submit the detailed post marketing surveillance (PMS) study report for their marketed drug products at the time of renewal application submission.
- This document provides harmonized standards on the planning, preparation, conduct, and reporting of risk-based pharmacovigilance inspections of MAHs for medicinal products approved for marketing in India.
- A comprehensive pharmacovigilance (PV) guideline has been drafted which will be finalized after deliberations with the stakeholders of such products, and accordingly, a meeting of the stakeholders was organized on September 24, 2018. The meeting was attended by the representatives of the Indian Drugs and Pharmaceutical Association Forum, Pharmacovigilance Programme of India, Indian Society for Clinical Research, AEFI Secretariat, and many pharmaceutical companies in which the guideline was presented and discussed with participants during the meeting.
- The guideline is now placed on the official website for public view and further consideration. The stakeholders' comments and suggestion are hereby requested for further improvement. All such feedback should be acceptable till October 31, 2018, at E-mail: email@example.com and firstname.lastname@example.org.
| Public Notices on Video-Conferencing Facility for Promotion of Innovation and Start-Up Business in India in Pharmaceutical Sector|| |
- A public notice was issued by CDSCO dated July 20, 2018 (File no. X-11026/003/18-PRO). Vide this notice, it was stated that a direct video-conferencing (VC) facility should be provided to entrepreneurs, researchers, and innovators in line with the mission of Ease of Doing Business and Make in India Initiative of Government of India.
- It was informed vide this notice that the timing of VC facility will be from 10 am to 5.30 pm on all working days with prior appointment of the office of DCG(I).
- A follow-up public notice was issued by the PRO at CDSCO dated October 3, 2018, wherein all the stakeholders were once again informed to utilize this Video–conferencing facility by taking appointment along with details of proposal in prescribed format at email@example.com.
| Order on Modification of Office Order on Submission of Serious Adverse Event Reports|| |
- An order was issued by CDSCO dated October 25, 2018 (File no. D.21013/159/2018-DC), wherein a partial modification of an earlier CDSCO order dated August 20, 2018, related to SAE submission was made.
- Vide the above-mentioned order, it was notified that only receipts related to SAEs of clinical trials ongoing in India with which the SAE division is concerned will be accepted by SAE division situated at Sadiq Nagar, New Delhi.
- Vide this order, it was clarified that the receipts of SAEs including CIOMS/ notifications/ SUSAR/ Adverse events of marketed drugs occurring outside India and SAE reports of PMS/ PSUR/ Academic trials/ observational/ Non-interventional studies of marketed products will not be accepted by SAE division situated at Sadiq Nagar with immediate effect and the same will be accepted by CRU, FDA Bhawan, New Delhi for processing by the concerned divisions.
- A subsequent order was issued by CDSCO dated October 29, 2018 (File no. 21013/159/2018-DC), regarding the above subject. Vide this order, it was further notified that the above-mentioned order dated October 25, 2018, was kept in abeyance till further orders.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |