|Year : 2020 | Volume
| Issue : 4 | Page : 182-184
Indian Regulatory Update-2 during the COVID-19 pandemic
Novartis Healthcare Private Limited, Mumbai, Maharashtra, India
|Date of Submission||02-Oct-2020|
|Date of Acceptance||03-Oct-2020|
|Date of Web Publication||28-Oct-2020|
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
|How to cite this article:|
Bhave A. Indian Regulatory Update-2 during the COVID-19 pandemic. Perspect Clin Res 2020;11:182-4
This article provides important regulatory updates issued in India during the COVID pandemic covering period from June 2020 to September 2020.
| Related to Diagnosis, Prevention, Treatment, and Management of COVID-19|| |
Notification regarding hand sanitizers
- The Ministry of Health and Family Welfare (MoHFW) issued a notification No. S.O. 2451 (E) dated July 27, 2020. In the current emergency situation due to COVID-19, availability of hand sanitizers to public at large is essential. Vide this notification, hand sanitizers were exempted from the requirement of sale license for its stocking or sale, provided condition (17) of Drugs and Cosmetic Rules (65) is followed.
Draft regulatory guidelines for development of vaccines with special consideration for COVID-19 vaccine
- The Central Drugs Standard Control Organisation (CDSCO) office on September 21, 2000, issued DRAFT guidelines for the development of vaccine with special consideration for COVID-19 vaccine. This 40-page guideline document included topics such as Introduction, Background, Chemistry Manufacturing and Controls, Nonclinical Development Program, Clinical Development Program, and References.
- Further to this, the CDSCO office issued a notice dated September 21, 2020, regarding information on the above-mentioned DRAFT regulatory guidelines. In the current pandemic situation, a need was felt to develop comprehensive guidelines on vaccine development for better understanding of vaccine developers. It was stated in this notice that these guidelines are dynamic and recommendatory in nature. Vide this notice, stakeholders were requested to forward comments on the draft guidelines, if any, by October 12, 2020.
| Related to Clinical Trials during the COVID-19 Pandemic|| |
Notice regarding conduct of Bioavailability and Bioequivalence (BA/BE) studies for export purpose
- A notice (No. 12-09/BA-BE/2020/MISC-18/DC) was issued on June 9, 2020, by the CDSCO office regarding challenges/difficulties faced during the conduct of BA/BE studies including adherence to approved protocol, applicable procedures, and regulatory guidelines, considering the pandemic situation. Vide this notice, it was re-emphasized that protection of rights, safety, and well-being of trial subjects is of paramount importance.
- The Sponsor and BA/BE center were advised to do assessment and take appropriate decision in consultation with investigators and ethics committees to ensure the safety and well-being of trial subjects and must be in accordance with guidance and circulars issued by the local health authority.
| Related to New Drugs, Import/manufacturing of Drugs, and Medical Devices during the COVID-19 Pandemic|| |
Compassionate use draft guidelines
- The MoHFW issued G.S.R. 354(E) dated June 05, 2020. Vide the said G.S.R, a DRAFT amendment to New Drug and Clinical Trial Rules 2019 in Chapter XI after Rule 96 was proposed. Objections and suggestions if received from any stakeholders within a specified period of 15 days from the release date would be considered by the central government.
- Rule 96A, B, and C included details of application, grant, and condition of license for import of unapproved new drug for compassionate use for treatment of patients by hospitals and medical institutions.
- Rule 96D, E, F, G, H, and I included the details of application, grant, condition, inspection, suspension, and license to manufacture of new drug for compassionate use.
Circular regarding residual shelf-life of imported drugs
- Earlier, on April 17, 2020, the CDSCO had issued a circular (F. No. DCGI/Misc/2020/(110)), wherein it was stated that considering challenges during the COVID-19 situation to ensure continued supply of drugs to Indian patients, drugs having residual shelf-life <60% may be permitted for import based on certain undertaking from the importer, and this circular was valid for a period of 3 months from the circular date. In continuation of this circular, the CDSCO issued another circular dated July 10, 2020 (F. No. DCGI/Misc/2020 (110)), mentioning that effective date of previous circular shall be valid till October 31, 2020, or till further orders, considering the current pandemic situation.
Notification regarding validity of registration certificates
- The MoHFW issued a notification No. S.O. 2450 (E) dated July 27, 2020, regarding the validity of registration certificates.
- It was mentioned here that there are several registration certificates in form 41 valid for a period of 3 years which are likely to expire shortly. Considering the COVID-19 situation and to ensure that the supply of drugs should not get affected, pharma companies had requested for extension of validity of such form 41s.
- Vide this notification, it was stated that if the registration certificate holder had made an application for fresh registration certificate before expiry of the same, the existing registration certificate shall be valid until orders are passed on the application.
Notice regarding submission of notarized/apostilled documents for import of cosmetics and medical devices
- A notice was issued by the CDSCO Cosmetic division dated August 19, 2020 (No. COS/Misc./31/20) which stated that considering the COVID pandemic, an applicant may submit applications for import registration along with the required documents which are self-attested and an undertaking to submit notarized/apostilled documents with legal signatures once the situation normalizes or within 4 months, whichever is earlier. The CDSCO will process the application and if satisfactory, issue the licenses with condition to submit the notarised/apostilled documents after normalization of situation.
- The CDSCO office had earlier issued a notice dated April 23 (No. 29/Misc/03/2019-DC (60)), wherein it was stated that an applicant may submit application for import registration of medical devices and in vitro diagnostic kits with documents which are self-attested and an undertaking that apostilled/notarized documents will be submitted after normalization of the situation or within 4 months, whichever is earlier. In continuation of the same, the CDSCO office Medical Devices and Diagnostic division further issued a notice dated August 31, 2020 (No. 29/Misc/03/2019-DC (134]), wherein it was stated that the effective date of the earlier-said notice was extended for a further 4 months or till normalization of the situation.
Notice regarding fees for change of address of authorize agents for medical devices
- The Medical Devices and Diagnostic division of CDSCO issued a notice dated August 31, 2020 (No. 29/Misc/03/2020-DC (124)), wherein it was clarified that fees may not be required for change of address of authorized agents without change in constitution under the Medical Devices Rules, and this was based on various representations received by the CDSCO office.
Notice regarding online application for medical devices
- The Medical Devices and Diagnostic division of CDSCO issued a notice dated September 3, 2020 (F. No. 29/Misc/03/2020-DC (205)). It was stated that applications for issuance of Free Sale Certificate, Market Standing Statement, and Non-Conviction certificate of notified Medical Devices is now functional on the online system of Medical Devices Portal.
- It was further mentioned that offline submission for such applications will not be accepted after September 30, 2020.
Notice regarding classification of non-notified medical devices
- The Diagnostic Division of CDSCO issued a notice dated September 3. 2020 (F. No. IVD/Misc/196/2020) regarding non-notified medical devices. It was stated that in continuation of earlier notices, the Central Licensing Authority needs to classify such devices as per risk-based approach.In vitro diagnostic medical devices are classified under three categories, which is provided as Annexure I, and will be examined as per the international classification and MDR 2017.
- The Medical Device Division of CDSCO issued a similar notice dated September 3, 2020 (F. No. 29/Misc/03/2020-DC (200)) regarding non-notified medical devices. All such medical devices were classified into 24 categories, which is available in Annexure II with this notice.
- Vide both these notices, stakeholders were requested to provide comments within 30 days of the said notices.
Notice regarding documents for import
- The CDSCO Import and Registration Division issued a notice dated September 17, 2020 (F. No. Import/Misc/89/2015-DC), wherein it is stated that all importers are required to furnish labels, Certificate of Analysis (CoA), import license, and bill of entry along with other documents at the port office, and this is for necessary action for utilize ICEGATE.
| References|| |