NABH Announcement

NABH Announcement

Fire Safety Compliance in all Certified / Accredited Hospitals

In view of many reported recent fire accidents, all the NABH Accredited/ Certified Healthcare Organizations are requested to comply with the following:

  • To review their Fire Safety Plans, policies and equipment and also update the names of designated Fire Safety Officers in case required.
  • To conduct extensive fire safety mock drills and trainings including mock evacuation of critical patients, checking the functionality of the fire hose reel etc.
  • To review and resubmit their updated Fire NOC / application for renewal to the secretariat. In case NOC is not applicable, as per the state laws, third party audit is to be provided.
  • The necessary document much be uploaded in the respective online portals (all accredited Hospitals as well as the HOPE Old Portal Organizations).
  • HOPE Certified organizations can mail the document with their reference number to :
    admin.hope@qcin.org
  • This is for all partner organizations, across programmes.
  • The exercise must be completed at the earliest but no later than 31st January 2021.

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.

FSSAI Notification

Standards for fortification of processed food products

FSSAI notifies norms for permissible levels of micronutrients for fortifying processed food products.

In the wake of setting stronghold principles for staples, the Food Safety and Standards Authority of India (FSSAI) has advised standards for passable degrees of micronutrients for fortifying food items that are processed, for example, breakfast oats, breads, biscuits, rusks, noodles, pasta, buns and juices.

Manufacturers should abide by the set standards by next year.

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 .