REGULATORY UPDATE

Year : 2020  |  Volume : 11  |  Issue : 3  |  Page : 132-134

Indian regulatory update during the COVID-19 pandemic

Amita Chandan Bhave
Novartis Healthcare Private Limited, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Amita Chandan Bhave
Novartis Healthcare Private Limited, Inspire BKC, Part of 601 and 701, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051, Maharashtra
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/picr.PICR_182_20

Related to Diagnosis, Prevention, Treatment, and Management of Covid-19

• Two notices (no. X-11026/07/2020-PRO) were issued by CDSCO office both dated March 19, 2020,^[1],[2] discussing about drugs/vaccines and diagnostic kits for COVID
• In both the circulars, it was stated that in order to enhance the research and development ofin vitro diagnostic kits for COVID diagnosis or drugs/vaccines for prevention or treatment of COVID, CDSCO will process any such application on high priority and CDSCO will also provide guidance for regulatory pathway on such matters
• It was notable to read that any applications for manufacture or importin vitro diagnostic kit for test, evaluation, and further use in performance evaluation may be processed on priority within 7 days
• In the circular on drugs/vaccines or clinical trial applications for COVID, it was commented about plans for expedited review/accelerated approval for marketing in India. It was also stated that in case of emergency, import license (form 10) would be granted without registration certificate (form 41) subject to approval of the central government.

• The CDSCO has been regularly updating the list of approved COVID-19 testing kits such as polymerase chain reaction (PCR) and RAPID/CLIA/ELISA kits on its website
• The CDSCO office issued a list of PCR kits approved for COVID-19 testing on various dates and recently updated it on June 8^[3]
• Further, the CDSCO also issued a list of RAPID/CLIA/ELISA kits for testing on various dates and recently updated it on June 8^[4]
• These lists also included name of the firm, type of kit, and country name.

• The CDSCO office issued a notice (no. DCGI/MISC/2020/96) dated April 7^[5] addressing all state/union territory (UT) drug controllers
• To ensure the availability and supply of oxygen for medical use during COVID, premises having facility to manufacture industrial oxygen for medical use should be granted manufacturing license to manufacture oxygen for medical use within 24 h of receiving application, fees, etc.

• The Ministry of Health and Family Welfare issued a notification (no. S. O. 1511 (E) dated May 18, 2020,^[6] wherein it was stated that in public interest, it is necessary and expedient to regulate the manufacture and stock for sale or distribution of vaccine for the prevention and treatment of COVID-19 infection. This notification appears to be issued for lessening the timelines for vaccine development for Covid-19 by allowing applicants to submit the application for manufacturing during the conduct of clinical trial and allow manufacturing and stocking of drugs; however, applicants can sell or distribute only once new drug permission is secured from the Health Authority (HA). This will reduce the time to market for the local manufacturer of COVID-19 vaccines.

• An advisory notice (no. DCGI/Misc/2020 (119)) was issued by the CDSCO office dated May 22, 2020,^[7] wherein it was highlighted that all the manufacturers of personal protective equipment (PPE) kit coveralls be aware of the latest rules governing medical device, and PPE coverall manufacturers may consider voluntary registration on the CDSCO Medical Device online portal, i.e., cdscomdonline.gov.in to secure a registration number from the CDSCO as a benchmark for their quality.

Office Memorandum Regarding Rapid Response Regulatory Framework for Covid-19 Vaccine Development

• An office memorandum (no. BT/03/27/2020-PID) was issued by the Ministry of Science and Technology Department of Biotechnology regarding Rapid Response Regulatory Framework for COVID-19 Vaccine development, dated May 26, 2020^[8]
• Vide this memorandum, it was informed that a Rapid Response Regulatory Framework for fast-track processing of applications relating to recombinant vaccines for COVID-19 has been developed for information and necessary action by all stakeholders
• A guidance note was issued which comprised a checklist for preclinical toxicity studies, consideration of preclinical data generated outside India, and consideration of data on clinical studies
• The guidance also mentions parallel application for conduct of clinical trials during preclinical studies and abbreviated pathway for COVID-19 vaccine development.

Related to Clinical Trials during the Covid-19 Pandemic

• The CDSCO released a notice ^[9] dated Mar 30, 2020 (no. DCGI/MISC/2020 (104)) regarding conduct of clinical trials during the COVID-19 outbreak. The letter mentions that protection of rights/safety/well-being of patients is of paramount importance and decisions should be taken in the interest of trial subjects. Further, it was specified that any communication between sponsor/ethics committee (EC)/investigator regarding the implementation of protocol amendments/deviations/modifications due to the current scenario may be sent via E-mail/any other electronic mode to Indian HA.

• A circular (no. 7-5/2020/Misc/070) was issued on April 30 by the CDSCO office ^[10] regarding consideration of extension of validity of BA/BE study centers based on various representations received from stakeholders
• It was concluded that the registration BA/BE study centers who have already applied or will apply for renewal of registration 90 days prior to the date of expiry with requisite documents/fees will remain valid until any order is issued by the CDSCO otherwise.

Indian Council of Medical Research Guidelines for Ethics Committees during Covid-19

• The Indian Council of Medical Research (ICMR) has released, on May 6, 2020,^[11] National Guidelines for Ethics Committees reviewing Biomedical and Health Research (April 2020) to support the ethical conduct of research in India during the COVID-19 pandemic. The ICMR Bioethics unit, NCDIR Bengaluru, has developed this document under the guidance of COVID-19 National Ethics Committee, highlighting the important role of ECs in conducting ethical research in India in such times. The guidelines include statement of general principles, general ethical issues, ethical review procedures, informed consent, and vulnerability.

Related to New Drugs, Import/manufacturing of Drugs during the Covid-19 Pandemic

• In order to ensure continued availability of vaccines and an essential drug and considering the challenges of logistics and workforce, a circular (no. X-11026/65/2020-BD) was issued by the CDSCO office dated April 3^[12]
• It was stated that during lockdown, CDL Kasauli may carry out lot release for human vaccines manufactured domestically by a review of a summary lot protocol on a case-by-case basis. This was subject to the condition that the manufacturer shall forward a summary lot protocol of each batch/lot to CDL Kasauli through E-mail along with Certificate of Analysis (CoA) and an undertaking regarding recall in case of quality failures. Once situation normalizes, vaccine manufacturers shall send samples to CDL Kasauli as per usual procedures, for evaluation and further lot release.

• Two notices were issued by the CDSCO on April 15 (no. Import/Misc/101/2020-DC) and April 23 (no. 29/Misc/03/2020/DC (60) for drugs and medical devices, respectively,^[13],[14] which stated that considering the COVID pandemic, an applicant may submit applications for import registration along with required documents which are self-attested and with an undertaking to submit notarized/apostilled documents once situation normalizes. The CDSCO will process the application and if satisfactory, issue the licenses with condition to submit the notarized/apostilled documents.

• The CDSCO office issued a notice (no. 7-5/2020/Misc/070) dated May 1,^[15] addressing all state/UT drug controllers
• Considering the COVID outbreak and in order to maintain the continuity of essential activities by pharmaceutical industries, validity of certificates such as WHO Good Manufacturing Practice/Certificate of pharmaceutical Products expiring from March to August 2020 may be extended by 6 months from the date of expiry of certificate.

Related to Miscellaneous during the Covid-19 Pandemic

• The CDSCO office issued a notice (no. DCGI/MISC/2020/(99) on March 23^[16] regarding emergency situation arisen out of the COVID-19 outbreak. It was mentioned that due to lockdown, various applicants were unable to collect permissions/queries/clarifications, and it was stated to send it on E-mail IDs of applicants urgently in public interest.

References

1.	Notice Dated 19-Mar-20 Issued by CDSCO (No. X-11026/07/2020-PRO). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc2OQ==. [Last accessed on 2020 Jun 11].
2.	Notice dated 19-Mar-20 issued by CDSCO (No. X-11026/07/2020-PRO). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc3MA==. [Last accessed on 2020 Jun 11].
3.	List of PCR Kits Approved for Testing of COVID-19 Dated 08-Jun-20 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk3Nw==. [Last accessed on 2020 Jun 11].
4.	List of Rapid/CLIA/ELISA Kits Approved for Testing of COVID-19 dated 08-Jun-20. Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk3OA==. [Last accessed on 2020 Jun 11].
5.	Notice Dated 07th Apr-20 Issued by CDSC) (No. DCGI/MISC/2020/96). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTgzNQ==. [Last accessed on 2020 Jun 11].
6.	Notification Dated 18-May-20 Issued by Ministry of Health and Family Welfare (No. S.O. 1511 (E) dated 18-May-20. Available from: https://prsindia.org/files/covid19/notifications/6432.IND_vaccines_May18.pdf (). [Last accessed on 2020 Jun 11].
7.	Advisory Notice Dated 22nd May-20 Issued by CDSCO Office (No. DCGI/Misc/2020(119)). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk1MQ==. [Last accessed on 2020 Jun 11].
8.	Office Memorandum Dated 26-May-20 Issued by Department of Biotechnology (No. BT/03/27/2020- PID). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk1NA==. [Last accessed on 2020 Jun 11].
9.	Notice Dated 30-Mar-20 Issued by CDSCO (no. DCGI/MISC/2020 (104).
10.	Circular Dated 30th April-20 Issued by CDSCO (No. 7-5/2020/Misc/070). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg5Nw==. [Last accessed on 2020 Jun 11].
11.	National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic. Available from: https://www.icmr.gov.in/pdf/covid/techdoc/EC_Guidance_COVID19_06052020.pdf. [Last accessed on 2020 June 11].
12.	Circular dated 03rd Apr-20 Issued by CDSCO (No. X- 11026/65/2020-BD)). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTgxNg==. [Last accessed on 2020 Jun 11].
13.	Notice dated 15th Apr-20 issued by CDSCO (No. Import/Misc/101/2020-DC). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg1MQ==. [Last accessed on 2020 Jun 11].
14.	Notice Dated 23rd Apr-20 Issued by CDSCO (No. 29/Misc/03/2020/DC (60). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg4NQ==. [Last accessed on 2020 Jun 11].
15.	Notice dated 01-May-20 issued by CDSCO (No 7-5/2020/Misc/070). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg5OA==. [Last accessed on 2020 Jun11].
16.	Notice dated 23-Mar-20 issued by CDSCO (No. DCGI/MISC/2020/(99)). Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc4MQ==. [Last accessed on 2020 Jun 11].

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