CDSCO Fresh Notification

Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as
Drugs with effect from April 1st, 2021
– Fresh Notification from CDSCO

Notification from CDSCO – Released on 3rd Nov 2021

Notification Highlights : CDSCO

Stakeholders have now represented their concerns that due to Covid-19 disruption there is unpreparedness in complying with regulatory requirements within the prescribed timelines, which may lead to disruption of supply chain & access to patients.

Therefore, in order to ensure smooth transition of manufacturers/importers, continuity of supply chain and access to the patients, with the approval of MoHFW, it has been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, as the case may be, for grant of import/manufacturing license in respect of the said device(s) under provisions of MDR, 2017 by 18.04.2021, the said application shall be deemed to be valid and the importer/manufacturer, can continue to import/manufacture the said device(s) up to 30.06.2022 or till the time the Central License Authority or State License Authority, as the case may be, takes a decision on the said application, whichever is earlier.

Further, the applicant, in case has submitted an incomplete application (submitted by or before 18.04.2021), is required to ensure submission of all the necessary documents to the concerned Authority, by 31.03.2022

Central Licensing Authority or State Licensing Authority, as the case may be, shall dispose of these applications within three months from the date of receipt of complete application.

Further, the importer/manufacturer of above said medical devices has to obtain import/manufacturing license for the above said devices by or before 30th June, 2022. The importer/Manufacturer shall necessarily be required to print the import/manufacturing license number on the label with effect from 1st of July 2022.

BA BE Centres Regn Process

CDSCO Announcement – BA BE Centres to apply online for Registration Process

CDSCO to move application process for registration of centers for BA/BE studies online from Oct 15 2021

CDSCO has released a notification recently on registration process for BA/ BE Centers.

The National Drug Regulator has switched the applications for registration of bioavailability/bioequivalence (BA/BE) studies from the industry, from physical to digital from the middle of this month – 15th Oct 2021. This is in line with the Central Drugs Standard Control Organisation’s (CDSCO) efforts to implement an e-governance mechanism in the organisation.

The Drugs Controller General (India) Dr V G Somani, in a notice, said that the CDSCO, in collaboration with Centre for Development of Advanced Computing (CDAC), has developed a module for online processing of applications for registration of BA/BE study centres in accordance with New Drugs and Clinical Trial Rules, 2019.

The module is finalised and has been made functional, which can be accessed through the dedicated website of CDSCO. The drug regulatory also requested all concerned stakeholders to avail the facility and welcomed any comments or suggestions to help improve the module.

“Thereafter, the BA/BE centre registration applications processing will be online and physical applications may not be accepted after October 15, 2021, in this regard,” said the notice.

The move comes as CDSCO’s efforts to implement the e-governance mechanism with various online services launched through the Sugam portal on November 14, 2015.

On September 30, the CDSCO has said that the submission of applications on Post Approval Changes in bioavailability (BA)/bioequivalence (BE) study permission and import license for export purpose is functional on online system of Sugam portal, in order to streamline the regulatory submission procedure.

“The facility of offline submission of applications in hard copy or through e-mail may not be available after October 8, 2021, for processing,” said a notice, issued to all stakeholders, State and Union Territory Licensing Authorities and others.

The Sugam e-governance portal has been designed as a single window system for all the stakeholders to access the services provided by the portal, by implementing role based access control and actions. It has consolidated the entire drug regulatory framework at centre and provides a centralised dashboard for monitoring various regulatory clearances all over the country.

The portal is well integrated with the e-Nivesh that is the National portal to provide the project proponent/entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes. SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/ license, online payment, online review process, query management and grant of permission/license online. Sugam portal internally builds the database of drugs & manufacturers and their current regulatory status (approved/ banned) in India, according to C-DAC, which created the portal.

Source : http://www.pharmabiz.com/NewsDetails.aspx?aid=143001&sid=1

CDSCO Notification

Download the Notification from CDSCO here

Notification from CDSCO

Fresh Notification – Voluntary Registration & Labelling Norms from CDSCO for Medical Device Industry

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. CDSCO has called for feedback , suggestion from the industry to the proposed amendments.

Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification below.

NOTIFICATION – New Delhi, the 12th October, 2021

G.S.R. 729(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public;

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to

The Under Secretary (Drugs Regulation),
Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan,
New Delhi – 110011
or
emailed at – drugsdiv-mohfw@gov.in.

DRAFT RULES

(1) (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

(2) In the Medical Devices Rules, 2017(hereinafter to be referred as said rules), in rule 19B, in subrule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(3) In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

(4) In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt , it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(5) In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

Download the Notification from CDSCO

Source : CDSCO

FAQs Session With CDSCO

Medical Device Regulations – Non Notified Devices – Voluntary Registration ProcessSeptember 19th 2021, Sunday – 4 PM – 5 PM

Let Our REGULATOR Speak to You !

Do Join Us to get answers to your FAQs on Voluntary Registration Process !

Voluntary Registration Process rolled out by CDSCO for Non Notified Devices is coming to an end by Sep 30th 2021. Industry Forums are receiving so many FAQs from various stakeholders over the last 2 months asking many questions on Voluntary Registration Process and raising wide range of questions on WHAT HAPPENS FROM OCTOBER 1ST 2021.

Hence AIMED (Association of Indian Medical Device Industry) is organising a session to enable the industry, stakeholders to get their FAQs addressed from the Regulator.

Some of the FAQs raised by stakeholders are captured below and we invite industry, stakeholders to register and join the session to discuss pertinent issues , challenges faced, if any.

This program is the initiative of AIMED , a leading Industry Platform for Make in India Manufacturers representing the Voice of the Industry.

Program Information :

Some FAQs from Industry which need information from CDSCO :

Registration Details :

Who Should Attend ?

Program is Open for all Industry Members, Stakeholders like Manufacturers, Traders, Distributors, Startups, Med Tech Businesses etc.

There is NO REGISTRATION FEE but Prior Registration is a MUST.

Registered Participants shall get Email Confirmation 2 days before the session from Consultants Consortium of Chennai .

Registration Link

Download the program collaterals from here

Contact Co-ordinates :

Ms Rama Venugopal
Email – contact@ccc-consultants.org
WhatsApp – +91 9840870532

Mr D Srikanthan
Email – secretariat@ccc-consultants.org
WhatsApp – +91 9003056539

Medical Device – Product Recall

Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO

Medical Device Alert on Ventilator of Philips Announcement from CDSCO

Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI)Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:

Dear Healthcare Professionals,

As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM3MQ==

Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.

If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :

https://www.ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf

Please email your feedback along with duly filled field safety form to :

Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.

Downloads :

About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/

About IPC – https://www.ipc.gov.in/

About MVPI Program Launched by IPC :

Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.

Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.

For more information about MVPI, download the document below :

Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :

Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.

Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.

Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.

Advisory on Oxygen Concentrators from CDSCO

COVID-19 case management in Home Settings

How to spot a good oxygen concentrator ?

Oxygen concentrators with a flow capacity of less than five litres per minute are “not suitable” for COVID-19 patients on home care and should not be used, India’s drug regulator , CDSCO said . Sellers should not push such devices using “misleading label” amid the coronavirus second wave.

The advisory by CDSCO aims at educating the people about minimum standards of oxygen concentrators for COVID-19 case management, especially for use in home settings.

At present , market has various models of oxygen concentrators, with different capacities of continuous flow (1 to 10 litres/minute) and widely varying concentration of oxygen, are being marketed . The health ministry has from time to time advised that oxygen concentrators with flow capacity of five litre per minute or more and delivering oxygen with concentration of 90 per cent or more are suitable for management of COVID-19 patients at COVID Care Centres, Dedicated COVID Health Centres and in home settings. The World Health Organisation has also prescribed these norms for oxygen concentrators.

Many people are not aware about these minimum parameters of oxygen concentrators and therefore may be using the concentrators that are not suitable for COVID-19 case management. This advisory is issued to inform people about minimum standards of oxygen concentrators for COVID-19 case management, for use especially in home settings.

CDSCO has further advised that oxygen concentrators must be purchased with consumables required to operate, user care instructions and protocols including guidance for replacement of accessories and consumable and safe decontamination of reusable parts, indicating if they are generic or brand related, the advisory said.

CDSCO has strongly advised that all sellers must prominently display the following information for each model of oxygen concentrator for sale

  • continuous flow capacity in litres per minute
  • the percentage of oxygen that a concentrator generates and
  • the maximum retail price.

Download the full advisory here for more information

New Cosmetics Rules 2020

New Cosmetics Rules 2020

Announcement from CDSCO – 15th Dec 2020

CDSCO has announced the revised Cosmetics Rules 2020 under Drugs and Cosmetics Act , 1940

The Ministry of Health and Family Welfare notified the Cosmetics Rules2020, on December 15, 2020, with an aim to separately codify and update the rules relating to import, manufacture, labelling, sale and distribution of cosmetics in India, which were earlier set out under the Drugs and Cosmetics Rules, 1945.

The ministry issued the notification in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940). These rules shall be applicable to the cosmetic as defined in clause (aaa) of Section 3 of the D&C Act, 1940 (23 of 1940).

In these rules, unless the context otherwise requires, Act means the Drugs and Cosmetics Act, 1940 (23 of 1940);(b). Actual manufacturer in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by National Regulatory Authority or any authorised competent authority in that country for that purpose, by whatever name called for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.

As per the notified rules, authorised agent means a person in India authorised by the manufacturer. The authorised agent shall be responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act and rules made thereunder for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.

Bureau of Indian Standards (BIS)means the Bureau of Indian Standards established under Section 3 of the Bureau of Indian Standards Act, 2016 (11 of 2016).

No cosmetic shall be imported into India unless the product has been registered in accordance with these rules by the Central Licensing Authority or by any officer to whom such powers may be delegated under sub-rule (1) of rule 5.

An application for registration of a cosmetic product intended to be imported into India shall be made through the online portal of the Central Government in Form COS-1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer.

An authorisation by the manufacturer to his agent in India shall be duly authenticated either in India before a first class Magistrate or in the country of origin before the authority competent under the laws of that country or by an authority specified in the First Schedule.

The applicant referred to sub-rule (2) above shall furnish along with the application such other information and documents as specified in Part I of the Second Schedule provided also that in the event of application for import of bulk finished formulation ready to fill, the following additional documents shall also required to be furnished.

A registration certificate granted under rule 13 shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.

If the licensee fails to pay the required registration certificate retention fee on or before the due date as referred to in sub-rule (1), the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two percent of the registration certificate retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled.

In case of change in constitution of a registration holder or overseas manufacturer, after grant of registration under sub-rule (1) of rule 13, an application shall be made under sub-rule (2) of rule 12 for grant of fresh registration within a period of one hundred and eighty days from the date of such change in constitution provided that the existing registration shall be deemed to be valid till such time, fresh registration is issued or application is rejected by the Central Licensing Authority.

In case of any change in respect of labelling or composition or testing of registered product or its specifications, the Central Licensing Authority shall be informed by manufacturer or by the authorised agent or the importer or the subsidiary in India authorised by the manufacturer within fifteen days along with an undertaking that products comply with standards laid down by the Bureau of Indian Standards as referred in the Ninth Schedule.

The Rules lays down the provisions for the following :-

  • Chapter I Lays down the definition of the terms used in the Rules.
  • Authorities, Officers and Laboratory: The Chapter Lays down the provisions for Licensing Authorities, Delegation of powers of Licensing Authorities, Government Analyst and its functions, Powers, duties and functions of Inspectors specially Authorised to inspect manufacture and sale of cosmetics etc
  • Import and Registration:- The Chapter Lays down the provisions for Import of cosmetics, Grant of import registration certificate and its validity, Prohibition of import of certain cosmetic, Procedure for import of cosmetics etc
  • Manufacture of Cosmetics for Sale or Distribution:  The Chapter Lays down the provisions for Application for grant of license or loan license to manufacture cosmetics for sale or for distribution, Manufacture at more than one premises, Conditions of license or loan licence for manufacture of cosmetics, Grant or refusal of license, etc.
  • Permission for Import or Manufacture of New Cosmetic: The Chapter Lays down the provisions for Permission for import or manufacture of new cosmetic.
  • Labelling, Packing and Standards for Sale or Distribution of Cosmetics: The Chapter Lays down the provisions for Prohibition of sale or distribution, Prohibition against altering inscription on containers, labels or wrappers of cosmetic, Prohibition against false or misleading claims, Standards of cosmetics, etc
  • Procedure of Sampling For Test or Analysis, Seizure and Report: The Chapter Lays down the provisions for Testing of Cosmetic from a purchaser, Procedure for sampling, Manner of certifying copies of seized documents, Form of order not to dispose of stock, Procedure on receipt of sample, Issuance of certificates, etc
  • Approval of Laboratory For Carrying Out Tests on Cosmetics and their Raw Materials: The Chapter Lays down the provisions for Application for grant of approval for testing cosmetics, Inspection before grant of approval, Procedure of approving authority, Validity of licence, General conditions after approval etc.

The ministry issued the notification in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940). These rules shall be applicable to the cosmetic as defined in clause (aaa) of Section 3 of the D&C Act, 1940 (23 of 1940).

In these rules, unless the context otherwise requires, Act means the Drugs and Cosmetics Act, 1940 (23 of 1940);(b)?Actual manufacturer in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by National Regulatory Authority or any authorised competent authority in that country for that purpose, by whatever name called for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.

Medical Devices Regulation

Announcement from CDSCO

CDSCO has released a notification about the regulation of certain medical devices like blood glucose monitors, BP monitors, Nebulisers and Thermometers , the same is shared here

Medical Device Industry and other stakeholders including Hospitals, Diagnostics Sector, other healthcare orgns and patient communities have to follow the med dev regulations that are being announced on regular basis .