Medical Testing Labs

Regulations or Accreditations ??? – beginning of a new conundrum

Medical Labs are undoubtedly an important part of the health ecosystem in any country but in India, like many other sectors related to health and safety, they have remained largely unregulated and therefore lacking assurance of quality and reliability.

The Clinical Establishments Act, 2010 intended to fill this gap but unfortunately only 11 states and almost all union territories have adopted the Act till now and from all accounts none has enforced the minimum standards prescribed under it. Therefore, there is not even data on how many medical labs are operating in the country much less any measure of their quality. The role of medical labs came into sharper focus as covid pandemic set in and India scrambled to develop covid testing facilities.The question begs an answer not only in relation to covid testing but for the larger issue of assuring quality of medical labs in general in the country.

Read the informative post by Mr Anil Jauhri, International Conformity Assessment Expert about Medical Labs and whether they need Regulations or Accreditations in the country .

Source : Healthcare Quality News Letter from QAI – http://www.qai.org.in/

Parakh-Unified Laboratory Network

Govt of India initiative for mapping of labs and testing infrastructure in the country

“PARAKH” portal is a Government of India initiative for mapping of laboratory infrastructure across the country on a unified network of laboratories. This is a step towards enhancing Ease of Doing Business. This portal incorporates all the NABL accredited and Government recognized laboratories in the country on a Geographic Information System. This is an interactive and user friendly system to search laboratories and avail laboratory services, based on various parameters a user may require.

DPIIT Team said this portal should help to reduce compliance burden of the labs.

This may be the first step towards strengthening National Laboratories Quality Infrastructure in the country.

Source : DPIIT

Financial and Technical Assistance Schemes for Patent Filing and Quality Testing

Maharashtra Based Startups-CPY-CPY

Maharashtra State Innovation Society (MSInS), Govt. of Maharashtra is pleased to announce the launch of 2 key schemes to support startups in Maharashtra. Below are some details of these schemes:

  1. Intellectual Property Rights Support Scheme: With the objective of spreading awareness and providing assistance for IPR (Intellectual Property Rights), this scheme aims to offer financial assistance of up to INR 2 Lakhs for a domestic patent application and up to INR 10 Lakhs for an international patent application, subject to 80% contribution by MSInS, on a reimbursement basis.

Under this scheme, DPIIT-recognized startups incorporated in Maharashtra, with a revenue of less than Rs. 1 crore and funding of less than INR 3 crores shall be eligible for domestic patent support. DPIIT-registered startups incorporated in Maharashtra, with a revenue of less than INR 5 crores and funding of less than INR 3 crores shall be eligible for international patent support. In case the startup has raised funds of more than INR 3 crores, MSInS shall support up to 50% of the total cost (instead of 80%). Apart from financial support, technical assistance (for example access to empaneled attorneys, etc.) will also be provided in this scheme.

  1. Quality Testing and Certification Support Scheme for startups: Testing and certification of products for quality and assurance are an important and critical part of business for startups. However, these costs are high for startups in their formative years. The Scheme ensures that Government of Maharashtra will be reimbursing a part of quality testing costs incurred by Startups at NABL or BIS recognised labs.

Under this Scheme, DPIIT-recognized startups incorporated in Maharashtra, with a lifetime annual revenue in any financial year of less than INR 1 crore and funding of less than INR 3 crores shall be eligible for support of maximum up to INR 2 lakhs, subject to maximum 80% contribution by MSInS. 

This Scheme shall increase the competence of startups in product development and will also help them become more competitive in the domestic and export markets.

How to Apply

Applications are open now on first come first serve basis. Please visit MSInS website to check for eligibility and apply.  For any queries please email to team@msins.in or call on 02235543099

Registration

For more details, visit Maharashtra State Innovation Society @

https://www.msins.in/event-details/190

https://www.msins.in/

Pharmacovigilance in Hospitals

Reporting of Adverse Drug Reactions (ADRs) in Hospitals in India

Dr Srivatsan Bashyam, Principal Consultant

Email: srivatsan@valueadded.in

Virtual Training on Pharmacovigilance for NABH Accredited Hospitals was conducted by IPC – Indian Pharmacopoeia Commission , recently to create an awareness on Pharmacovigilance and Reporting of adverse drug reactions (ADRs).This write up prepared is based on the training given by IPC Team and various experts like Dr. Jai Prakash  Officer-in-Charge, PvPI, Mr Prashant Paschal, Assistant Director NABH QCI New Delhi, Dr. Vandana Roy AMC Coordinator MAMC-New Delhi, Dr. Rahul Shukla AMC Coordinator Yashoda Super Speciality Hospital, Kaushambi,  Ghaziabad  and my own search from various sources.

Pharmaceutical medicines are designed to cure, prevent or treat diseases; however, no medicine is without side effects and there are also risks particularly adverse drug reactions (ADRs) which can cause serious harm to patients.

It is been reported that adverse drug reactions (ADRs) are poorly reported in developing country including India. It is estimated that only 2-4% of adverse drug reactions (ADRs) are reported and only 10% of serious adverse drug reactions are reported world wide.

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human and helps in to reduce the harm to future patients.

What is ADR:

The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”

In addition to Drugs the vaccines, Medical Devices, Biosimilars, Diagnostic Agents are considered for ADR.

Classification of ADR:

Adverse drug reactions are classified into six types (with mnemonics):

Type A :dose-related (Augmented), 
Type B : non-dose-related (Bizarre),
Type C : dose-related and time-related (Chronic),
Type D : time-related (Delayed),
Type E :withdrawal (End of use),
Type F : failure of therapy (Failure).

A simple and common method of classifying ADRs is to divide them into two types – Type A and Type B. This is also known as the Rawlins–Thompson classification.

REACTIONTYPE A ‘AUGMENTED’TYPE B ‘BIZARRE’
Pharmacologically predictableYesNo
Dose-dependentYesNot clearly
IncidenceCommonUncommon
DetectionEarly in clinical developmentPost-licensing
MortalityLowHigh
ManagementReduce doseDiscontinue therapy

Who are at Risk of ADR :

  • Elderly

Patients taking medication from specific classes like –

  • Anti diabetics and Hypoglycemic Agents
  • Cardiovascular Drugs
  • Psychotropic Drugs
  • Anticonvulsants
  • Antineoplastic
  • Corticosteroids

Reporting of ADR:

All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to National Coordination Centre (NCC) or Adverse Drug Reaction Monitoring Centres (AMC).There are around 34 AMC centers in India. The pharmaceutical companies can also send individual case safety reports for their product to NCC.

Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC to report ADR. To remove language barrier in ADR reporting, the consumer reporting form are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm.The mobile Android application for ADR reporting has also been made available to the public.

Analysis of ADR:

There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.

The WHO-UMC causality criteria [WHO].

CausalityConditions (all conditions need to be complied with for each causality criterion)
CertainEvent/laboratory test abnormality with plausible time relationship to intake of a drug
Cannot be explained by disease or other drugs
Response to withdrawal plausible
Event definitive pharmacologically or phenomenologically
Rechallenge satisfactory, if necessary
ProbableEvent or laboratory test abnormality, with reasonable time relationship to drug intake Unlikely to be attributed to disease or other drugs
Response to withdrawal clinically reasonable
Rechallenge not required
PossibleEvent or laboratory test abnormality, with reasonable time relationship to drug intake Could also be explained by disease or other drugs
Information on drug withdrawal may be lacking or unclear
UnlikelyEvent or laboratory test abnormality, with a time to drug intake that makes a relationship improbable
Disease or other drugs provide plausible explanations
Conditional/ unclassifiedEvent or laboratory test abnormality
More data for proper assessment needed, or
Additional data under examination
Unassessable/ unclassifiableReport suggesting an adverse reaction
Cannot be judged because information is insufficient or contradictory
Data cannot be supplemented or verified

How to make the Hospital Adverse Drug Reaction Monitoring Centres (AMC):

The Hospital can send letter of intent to INDIAN PHARMACOPOEIA COMMISSION.
National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI),MINISTRY OF HEALTH & FAMILY WELFARE, GOVERNMENT OF INDIA
SECTOR-23, RAJ NAGAR, GHAZIABAD- 201 002.
Tel No: 0120- 2783392, 2783400, 2783401, Fax: 0120-2783311
e-mail: pvpi.ipc@gov.in, lab.ipc@gov.in, Web: www.ipc.gov.in

Laboratory Director Designation – ISO 15189 Standard Requirement

Designation of Lab Director, a QMS Specification, becoming a HR Issue in the Laboratory

Chithambaranathan Sivasubramonian, Associate Consultant

nathan@valueadded.in

Medical Laboratories & the need to create a dedicated Laboratory Director Post / Designation to satisfy QMS requirement

Isn’t this becoming a HR issue

A Laboratory Professional from a client organization reached out to us seeking clarification on Lab Director’s role in Accreditation process. She was asked by the Management to redesignate Lab Director as Lab head in Accreditation documents and she wanted to know if its ok to do so as Accreditation norm is asking for Lab Director designation.

This has triggered an internal discussion at office and we were debating about the need to create / insist on Lab Director’s designation / role in labs seeking accreditation.

Medical Labs were obtaining National / International Certifications, Accreditations all these years and each program has its own spec. However, the global trend in the last few years has shifted towards introducing Minimum Standards for Medical Labs and many countries have rolled out the program. India too has rolled out the Minimum Stds for Labs as Regulatory spec under Clinical Establishments (Registration and Regulation) Act, 2010.

Let’s take the case of a Lab appointing a Lab Director as an accreditation norm and see what is listed out by various National , International Stds for this requirement.

We have the following popular programs for Medical Labs running in our country :

  • Minimum Standards mandated under CEA. Both NABL, QAI offer Certification programs under this scheme in the country.
  • ISO 9001:2015 – Quality Management Systems Certification Program
  • Med Labs Certification Programs offered by NABH
  • Med Labs Accreditation Programs offered by NABL, CAP and QAI

Minimum Standards has mandated the Minimum qualification of Technical Head of Laboratory or Specialist or Authorized Signatories. Clearly defined spec on who should act as Technical head is mentioned. So any Certification program offered by NABL, QAI or any other body has to have the same spec in their Certification, Accreditation criteria as compliance to Minimum Standards is a Regulatory requirement.

ISO 9001:2015 Standard Clause 7 Support talks in general about Personnel competency, training needs etc. No other specification is listed as it’s a generic QMS Standard applicable for all businesses.

NABH Essential Standards for Medical Laboratories program talks about Personnel and its clearly mentioned about the Responsibility of Quality Manager & Technical Manager. But with respect to overall responsibility of the Laboratory Head, NABH Essential Standard for Medical Laboratories hasn’t mentioned anything much. So overall responsibility of Lab Head s not clear enough under this program.   

QAI’s Recognition for Medical Laboratory Program, in Human Resources section – MBBS Doctor or MSc Pathology/Medical Microbiology/Medical Biochemistry are recognized qualification for Authorized Signatory. But there is no evidence of defining the overall responsibility of the laboratory head and the same isn’t clear in the QAI Recognition of Medical Laboratory Program either.      

NABL’s Med Lab Accreditation Program mentions that Laboratory Director/ Head of Laboratory/ Technical Head (howsoever named), shall have the overall responsibility of Operations of the laboratory. Hence Lab Director’s Designation / Role is not mandatory. This is thee specific criteria document on NABL which is NABL 112. But the Standard for this program is ISO 15189:2012 which talks about the need to designate Laboratory Director.

CAP’s Laboratory Accreditation Program has a mandatory specification for Lab Director’s Designation and Role.

When 80-90% of the Labs in the country belong to Small labs category, can all qualify for Certifications, Accreditations. An ideal case is for Small labs to opt for Minimum Standards as 1st step towards the Quality journey before migrating to Certifications, Accreditations Programs. Compliance to Min Stds is also mandatory as it’s a Regulatory requirement.

My Thoughts as a Lab QMS Consultant :

I’m going back to the question asked by the Lab Professional whether its mandatory to have Lab Director Role and Designation in the Accredited Lab.

As a Consultant in healthcare industry, I would say it’s a debatable topic. The requirement depends on the National, International Standards followed by the Med Labs.

I have listed out the personnel spec given by each Standard for Med Labs. Lab Director’s Designation is a hierarchy in the organogram and can’t be maintained by all Labs. Labs can specify their own designations as listed in the NABL 112 Criteria OR criteria.

Webinar on Increasing Fire Accidents in Hospitals

Panel Discussion – Possible Reasons & Way forward to take Preventive Measures

In view of the recently reported fire accidents in the country, (both in dedicated Covid Care Centers and other Hospitals, including Nursing Homes), an increasing amount of intolerance is visibly seen at the market place from public, various stakeholders towards rising fire accidents in healthcare facilities. Recent SC order in Dec 2020 called for immediate fire audit inspection of all covid hospitals in the country.

A Webinar to brainstorm about the reasons for increasing Fire Accidents in Hospitals in the form of panel discussion is taking place on Feb 9th 2021 from 3 – 5 pm.

Two rounds of Panel Discussions focussing on Possible Reasons & Way forward to take Preventive Measures is designed.

Session is organised by Consultants Consortium of Chennai and supported by NABH , AHPI, QAI, UL India and FOCUS to kick start series of deliberations.

Who should attend ?

Hospital Promoters, Medical Professionals, CEOs, COOs, Facility Incharges, Building Mainteanance Teams, Biomedical Teams, Operations teams, HVAC Teams, Utility maintenance teams , QA Teams, Safety Consultants and Experts, Hospital Planners, Designers, Medical Planners, Architects, Electrical Safety Engineers, Civil Engineers

Date – Feb 9th 2021, Tuesday | Time – 3 pm – 5 pm

No Registration Fee. Prior regn is a must.

Regn Link – https://bit.ly/3oSMkWV

Full Program Info can be downloaded from

http://ccc-consultants.org/webinar-on-increasing-fire…/

Program is live telecast from CCC’s youtube page –

https://bit.ly/3a4mJWM

Contact Coordinators :

Rama Venugopal – 9840870532 – contact@ccc-consultants.org

D Srikanthan – 9003056539 – secretariat@ccc-consultants.org

Fire Safety Scenario in Indian Hospitals

Dr Bashyam Srivatsan
Principal Consultant
srivatsan@valueadded.in

In view of the recently reported fire accidents in the country, (both in dedicated Covid Care Centers and other Hospitals, including Nursing Homes), this post captures the latest initiatives from Ministry of Home Affairs, Govt of India to address the fire safety lapses and arrest the rising rate of fire safety incidents in covid care centres in the country.

The urgency of addressing the fire safety norms is triggered by the Apex court on November 27 ,2020 followed by  fire outbreak in the ICU of a designated COVID hospital at Rajkot in Gujarat in which five patients died. Apex Court  had pulled up the states for not taking any concrete action to mitigate the problem despite repeated instances.

The issue had cropped up before the top court which was hearing the matter in which it had taken cognisance regarding need for proper treatment of COVID-19 patients and dignified handling of dead bodies in the hospital.

The Centre informed the Supreme Court that it has directed all states and Union Territories (UTs) to send status report by December 4 on the implementation of fire safety guidelines to prevent fire incidents in hospitals or nursing homes.

Union Home Secretary has directed all the Chief Secretaries of states to ensure due compliance of the November 28 ,2020 directives regarding fire safety guidelines and to immediately re-inspect all hospitals or nursing homes to prevent fire accidents in future.

The government informed the apex court that all states and UTs have been asked to send their action taken reports (ATRs) on the enquiry conducted by them on fire incidents that have occurred in hospitals or nursing homes in the last five years.

All the states and UTs have been directed  by Central Govt to update their respective local building Bye-laws or Fire Service Act and to align and make them sync in line with ‘Model Bill on Maintenance of Fire & Emergency Services 2019’ circulated by Ministry of Home Affairs on September 16, 2019 read with other advisories issued from time to time under National Building Code of India.

NABH (National Accreditation Board Certifying & Accrediting Hospitals & other healthcare organisations for Quality and Safety practices), on its part has asked the NABH accredited & certified Hospitals to send the report by 31st January 2021 covering 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 NABH Secretariat. In case NOC is not applicable, as per the state laws, third party audit is to be provided.

The necessary documents must 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 at admin.hope@qcin.org

Having worked with around 100 plus healthcare facilities in the last one decade, starting from OP clinics, Nursing Homes, Small, Mid, Large Hospitals and upto 1500 bedded Medical College Hospitals etc in South India, we believe that the reasons for rising number of safety incidents are multifold.

We can classify the challenges in implementing Fire Safety compliances & protocols faced by healthcare orgns into following categories –

Infrastructure :

National building code is the base guideline document which specified guidelines for constructing Hospitals. It talks about roof height, staircase, Corridor, Emergency exit etc but very strangely the guideline is silent on constructing a ramp, a mandatory requirement in Hospital building having multiple floors.

Fire system having water storage tank, Hose reels, sprinklers, Fire sensors, Fire Extinguisher, jockey pump, fire pump etc also fall under infrastructure specifications listed in NBC. Unfortunately only very few hospitals have complied with all requirements in letter and spirit.

Manpower:

Dedicated Fire Safety Officer, at least 40% staff trained to handle fire equipments and extinguisher in each shift is lacking in majority of Healthcare organizations as majority of the hospitals don’t even have Safety Officers, Facility Management Teams with necessary skill and competency to handle emergencies.

Training :

Fire Safety training during induction and regular training of existing staff is mostly lacking in many Healthcare organizations.

Mock drills:

Normally conducted during accreditation process but not done on a regular basis to demonstrate the capabilities during real fire emergency scenarios. Safety practices are not inculcated as a culture post certification, accreditation process.

Fire License and Fire NOC :

Fire NOC is obtained by majority of the facilities , but the conditions of NOC are never implemented in totality , hence paving way for very few healthcare organisations obtaining the fire licenses. Majority of the hospitals are still outside this framework.

Way forward to make Safety Practices an Organisational Culture and how to meet the fire safety compliances mandated by statute :

  • Top management commitment is must for budgetary allocation and for right policy decision in this regard.
  • Take the help of fire department personnel or qualified & competent fire safety personnel (listed out in the NBC) to get list of requirements as part of compliances . A third party audit is useful to identify the GAPs in the system.
  • Maintenance or any other staff needs to be given role clarity and responsibility to coordinate with Management, Fire department, Fire equipment vendors and contractors etc to establish the fire safety system in the hospital and meeting all fire safety norms and licenses requirements as mandated as per local laws.
  • Once fire system is established Quarterly training to be given to all staff on fire safety protocols, handling fire safety equipments, evacuation of patient and staff, code red protocols etc
  • Fire Safety training should be made part of induction training programme for all new joiners which is not followed as a HR protocol in many healthcare organisations.
  • Regular maintenance of fire safety system to keep it battle ready.

Regulate Online Health Aggregators

Health Ministry Advisory to States, UTs

The Union Health Ministry has asked all states and UTs to implement a time-bound action plan for regulating online health service aggregators who have neither provided any details of laboratories on behalf of which they are providing services, nor their registration status, including compliance to minimum standards.

The ministry has further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws.

In a letter written to all states and UTs on January 19, Health Ministry Secretary Shri Rajesh Bhushan referred to an August 2020 order by the Delhi High Court which directed the ‘concerned authorities’ to initiate action against any illegal online health service aggregators operating in Delhi in violation of the ‘applicable laws’, including the Clinical Establishments (Registration and Regulations) Act, 2010.

Health Secretary said the laboratories and other clinical establishments, providing any type of medical services, are required to be registered either under the Clinical Establishments (Registration and Regulations) Act, 2010 (in those states/UTs where it is applicable) or under the state laws, as applicable.

This ministry has also notified in gazette, the minimum standards for laboratory services vide notifications dated May 21, 2018, and the amendment notification dated February 14, 2020, the letter stated.

Certain online health service aggregators, operational in various parts of the country, may perhaps be neither providing any details of laboratories, on behalf of which, they are providing services, nor their registration status, including compliance to minimum standards, Secretary said in the letter addressed to chief secretaries and administrators of all states and UTs.

The details of qualified staff, as required for running the laboratory services, may also not be available on their online portals.

“Health being a state subject, and keeping in view the directions of the Hon’ble Court in the above said order, it is requested, that a time-bound action plan may be made and implemented, as per the applicable laws, for regulating such online health service aggregators, and the related service providers, operational in your state/UT.

“It is further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws. It is further requested that an Action Taken Report may be sent to this Department on a priority basis,” the letter said.

Download the advisory issued by Dept of Health, MoH&FW

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.