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Everything About Import License of Drugs and Cosmetics in India

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Introduction

Indian is one of the developing countries that is expected to reach the milestone of developed country in a short span of time and Indian competency to provide with drugs and medical equipment’s has been collecting praises around the globe, since the decades. India is one of the biggest exporter of drugs and medical equipment’s to rest of the world. India has advanced since these past decades in the field of medicine which is considered as remarkable. India have started manufacturing medicines and new drugs and medical equipment’s since decades but the India’s advancement in this field has surprised the whole world. India has come far way along and go head to head with the developed countries and is now in the category of countries like America, Russia, and UK. Given the advancement, India is now becoming the hotspot for countries those who expertise in the field of medicines and medicinal equipment and these countries now desire to invest in India and use the Indian services. This may sound exhilarating and a boon for India but can be threat to India as well if the entry or production of any drugs or equipment is left unmonitored. Keeping in regards the fouls, The Government of India formed the Central Drugs Standard Control Organization, which is the national regulatory body controlled and governed by the Directorate General of Health Services, which comes under the gamut of Ministry of Health and Family Welfare. CDSCO is to India what Food and Drug Administration is to United States of America, Medicines and Healthcare Products Regulatory Agency is to United Kingdom, European Medicines Agency is to European Union and PMDA is for Japan. In the present time, everything is changing and so are the diseases and to fight against any new disease or for combating any infection or disease already present, it is absolutely necessary to make new drugs and before manufacturing and distributing any such drugs, it is vital to ensure that it would not cause harm in any other way. This is where CDSCO comes in, specialise in and help the people.

Expertise of CDSCO

As per Drugs and Cosmetics Act, State authorities are concerned with the regulation of sale, manufacture and distribution of drugs and CDSCO authorities are the ones responsible for approval of new drugs. CDSCO at central authority is the organization that regulates the functioning and responsibilities of approval of any New Drugs, Clinical Trials, Quality of imported drugs, conduct audit for WHO (World Health Organization), bring uniformity and transparency in its services, banning of drugs and cosmetics, laying down the standard for the drugs, coordination of the activities of the State Drug Control Organization and providing a vital element in the uniformity in the enforcement of Drugs and Cosmetic Act. CDSCO works to perform quality control tests as well with close context with Central Drug Laboratories. Government of India is expanding the scope of (CDSCO) Central Drugs Standard Control Organization by involving all medical devices including contraceptives and implants under the view of CDSCO. 


Having its head quarter at New Delhi, CDSCO has multiple zone offices throughout India. As per the Drug and cosmetic Act, State Authorities regulates the manufacture, distribution and sale of drugs, licensing of drug testing laboratories, approving of drug formulations for the purpose of manufacture, carry out inspections that may be post licensing or pre licensing. State authorities are also responsible to oversee the process of manufacture of drugs by respective states as well of those marketed in the state. And also the investigation and contravention of legal provisions. 


DCGI (Drug Controller General of India) comes under the array of Central Drugs Standard Control Organization as well. DCGI regulates medical and pharmaceutical devices under the gamut of Ministry of Health and Family Welfare. CDSCO works with Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) for regulation of imported drugs as authority while the Central Drugs Laboratory tests such drugs. It is further divided in zonal offices which are responsible for post market surveillance, post and pre licensing inspections and recalls. DCGI is the one who would approve any license of specified categories of Drugs like I.V. Fluids, blood and blood products, Vaccines and Sera. Manufacturers dealing with the authority shall name an AIR (Authorized Indian Representative) for the purpose of representation in deals with the CDSCO in India. 

Further CDSCO has 8 division

  1. BA/BE:- 

It is study relating to the pharmaceuticals and are quite important as well as can be threatening. CDSCO is the responsible to monitor such studies for the sake of safety of public. 


BA is the abbreviation for Bioavailability. Bioavailability means the amount and the rate of drug appearing in the systematic circulation. A drug’s relative amount from an administered dose that penetrates in the systematic circulation and also the rate of the appearance of the drug in the systematic circulation.  

 
BE is the abbreviation of Bioequivalence. It means the extent and rate of absorption of a drug product are not statistically and significantly different from the reference product which was administered at the same molar dose. 


The office of Drugs Controller General (India) is at CDSCO (HQ) FDA Bhawan, New Delhi. And has been busy as it is receiving constant applications from the applicant who requests to carry out BE/BA studies on Indian subjects for various pharmaceutical dosage formulations. But the application cannot be granted by the DCG (I) unless the tolerability of generics and demonstration of safety against the corresponding innovator drugs. And only after ensuring that these are comparable and safe for consumption. ’Vivo equivalence’ and ‘bioequivalence (BE)’ studies can help in the determination of an assessment of ‘interchangeability’ between the innovator product and the investigational. DCG (I) would also ensure that the documents submitted to the directorate for review and approval of BE-NOC for the purpose of export meets the tenets of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 as well as the Indian Good Clinical Practices Guidelines (GCP) guidelines.

 
The applicant desiring such services can submit the said application for Test License and BE NOC through online portal namely, Sugam Portal in the applicable checklist. Assistant Drugs Inspector/Drugs Inspector (Reviewing officer) will process the said application and then would send it to the ADC (I) (Nodal Officer) for further scrutinizing. The said application will be then regulated to DDC(I) (Deputy Decision Authority)/JDC(I) (Decision Authority) for the purpose of recommendation and approval and in lieu of that DCG(I) (Licensing Authority) would then grant the BE NOC & Test License to the applicant by the way of online Sugam Portal. 

  1. New Drugs:- 

With the passage of time, new drugs are becoming necessity more than a complementary. Given the present times, everyone in the entire world is waiting for a new drugs to fight the growing diseases in the world. And no new drug can be launched and be distributed without the license from CDSCO.


It is necessary to ensure that the drug is safe and worthy for use in humans before approving the said drug is approved for manufacture and marketing and import in the country. Drugs and Cosmetics Rules 122A, 122B, 122 DAB, 122DAC, 122DD and 122 E and Appendix I-XII of schedule Y, which describe the required data/information requisite for approval of clinical trial and to import or manufacture new drug for the purpose of marketing in the country.  


Rule 122A – Application to import new drug
Rule122B – Application for manufacture of any new drug
Rule 122 DA – DCG (I)’s Permission for conduct of clinical trial of new drug.
Rule 122 DAB – Examination of (SAE) serious adverse event of injury and death and payment of compensation in cases related to clinical trial.
Rule 1222 DAC – Conditions for clinical trial including requirement to follow GCP guidelines, requirement or guidelines in schedule Y of drugs and cosmetics act and other regulations.
Rule 122 E – New Drug definition
Schedule Y – Guidelines and requisites for clinical trial and approval in regards of new drug

New drugs defined under Law 122-E Drugs and Cosmetic Laws as a drug, including phytopharmaceutical drug or bulk drug substance that is not used in the country at a critical level under prescribed, suggested or recommended conditions for labelling and are not considered effective and safe by licensed licensing authority. A drug that has already been approved by the License Act referred to in Rule 21 for certain claims, now proposed to be marketed with modified or new claims, namely, indicators, rating, rating form (including continuous release form) and route of administration. A fixed-dose combination of two or more drugs, individually allowed to receive certain claims, now proposed to be combined for the first time in the prescribed dosage, or if the dosage of ingredients already marketed is proposed to be modified, certain claims, viz. indicators, dosage, dosage form (including continuous release form) and management route. All vaccines and Recombinant DNA (r-DNA) derived shall be new drugs unless otherwise approved by the Licensing Authority under Rule 21. The new drug will continue to be considered as a new drug for a period of four years from the date it was first approved.

  1. Medical devices:- 

At present times, only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.

  1. substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
  2. substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;


Amendments for this structure are expected soon from the government. Government is working on a bill to add more devices in this list. 

Some of the important regulations in relation to these devices are as:

  1. Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices.
  2. Grant of Import Licence. 
  3. Grant of licence or loan licence to manufacture for sale or for distribution.  
  4. Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.
  5. Grant of test licence to import for test, evaluation, clinical investigations, etc.
  6. Grant of license to Import investigational medical device by Government hospital or statutory medical institution for treatment of patient.
  7. Permission to conduct clinical investigation of Investigational Medical Device.
  8. Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device. 
  9. Permission to import or manufacture medical device which does not have its predicate device.
  10. Permission to import or manufacture new in vitro diagnostic medical device.
  11. Registration of Medical Device Testing Laboratory: 
  12. Preparation of Guidance and FAQ on key activities.
  13. Processing of application for Issuance of Free Sale Certificate for domestic manufacturers Medical Devices.
  14. Processing of application for Issuance of Market Standing Certificate and Non- Conviction for Medical Devices
  15. Complaint, Not of Standard Quality (NSQ) Verification.
  16. Updating the list as per the Classification of Medical Devices from time to time.
  17. Post Approval Changes in respect of Medical Devices.
  18. Constitution of MD experts committee.
  19. Inspection of manufacturing site for compliance of QMS by CLA/SLA.
  20. Capacity building activities of technical management.
  21. Preparing and submitting replies of Parliament Questions/RTIs/Clarifications/NOCs/ Port office queries
  22. Providing clarification to applicant on the regulatory status of products
  • DTAB (Drugs Technical Advisory Board) & DCC (Drugs Consultative Committee):- 

This is the division involved in convening and organizing meetings of Drugs Consultative Committee and Drugs Technical Advisory.

The functions of this committee is as follows:

  1. Co-ordination of the DTAB meetings under the Director-General of Health Services (DGHS) chairmanship for the purpose of advisory on technical matters arising out of the administration of the drugs and cosmetic ac to the central and state government. 
  2. Co-ordination of the meetings under the Drugs Controller General (India) chairmanship for the purpose of advisory on any matters tending to secure uniformity throughout India in the administration of the act, to the Central government, State government and the DTAB.
  3. Initiation of any amendments in the drugs and cosmetic act according to the recommendations of DTAB and co-ordination with the (MOHFW) Ministry of Health and Family Welfare for draft and final Notification in the Gazette.
  4. Consideration, examination and compilation of any suggestions/objections/comments received with respect to draft Public Notices/Gazette Notification/Circulars etc.
  5. Co-ordination of the constitution of sub-committees recommended as per the meetings of DTAB and DCC and further follow up for their respected reports. 
  6. Co-ordination of the meeting of the stake holders with respect to amendments in drugs and cosmetics rules, according to the recommendations from the ministry whenever required.
  7. Preparation of minutes of the meetings of DTAB and DCC and upload the same on the website of CDSCO for the reference of public/stakeholders.
  8. Processing of RTI’s/Public Grievances/representations with respect to Drugs and cosmetics act.  
  9. Some of the By-Laws of the Drugs Technical Advisory Board are:
  10. The Chairman of the Board shall determine the date, time and place of each meeting of the Board, provided that the Board meets at least once a year.
  11. The Chairman of the Board, where he is present, shall preside at all meetings of the Board. If the Chairperson is not present at any meeting, the members present shall elect from among them the person who will preside over the Chair of that meeting.
  12. Seven existing Board Members shall form the body.

 

(i) Notices of not less than 35 specific days of every meeting shall be given to each member of Board, provided that the Chairperson: -

  1. may charge, after giving the members in the notice not less than 15 days to the Bbard members, a special meeting at any time to deal with any urgent matter you need attention of the Board;
  2. call, after giving the members of the application no less than 15 specified days to board members, special meeting within one month of receipts for the required application to writing signed by at least seven members and stated a meeting to be called.


(ii) Notices will be sent to the latest address provided by the Secretary by board members.

  1. Any member wishing to present any resolution at a meeting of the Board shall make a representation in notice, in writing to the Secretary no later than 15 days before that date of the meeting, provided that in the case of a special meeting the notice shall not be less than 5 days.
  2. Each member of the Board shall have one vote, and in the event of a tie on any question to be decided, the Chairperson shall have a second or second casting vote.
  3. Any business, in which case the Board may be required to negotiate and decide otherwise as the Chairperson may direct that it be done in the presence of all members of the he Board should be present at a Board meeting. If three or more members show up, in writing, the desire that any particular topic be discussed in the meeting instead of by decree the broadcast should be set before the Board meeting.
  4. Any decision or report circulated in accordance with the Board or Chairman under Bye-Laws 7, and approved by a majority of the signatories as a commitment as a resolution adopted at a meeting of the Board, provided that at least nine
  5. Board members will be recording their views on the decision in support. The proceedings of each meeting, approved by the Chairperson accordingly, shall be communicated to the board members for approval or comment within 35 days from the date of the meeting.
  6. The required quorum for members of a sub-quorum appointed by the Board shall be determined at that time for the appointment of a subcommittee and must not be subordinate to a provincial majority of nominated members.
  7. The Chairperson and Secretary of the Subcommittee shall be appointed by the Board at the time for the appointment of a sub-committee.
  • Import and Registration:- 

  1. Chapter III of Drugs & Cosmetics Act 1940 & Part IV of Drugs & Cosmetics Rules 1945 regulates the import of Drugs into India. 
  2. Any applications for registration certificate & import license of drugs shall process according to the Rule 24 (A) & 24 of Drugs & Cosmetics Rules 1945. 
  • For this purpose drug includes— 

All medicines for external or internal use of human beings or animals and all substances intended to be used for or in the mitigation, diagnosis, treatment, or prevention of any disease or disorder in human beings or animals which includes, preparations applied on human body for the purpose of repelling insects like mosquitoes.

  1. Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette. 
  2. All substances intended for use as components of a drug including empty gelatine capsules. In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Rules 1945.

 

At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of drug (Section 3b of the Act) required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import. The application for Registration Certificate and import License can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturers having a whole sale License in the country through online application system “SUGAM”.

  • Biological Products:-

Biological products referred as biologics, are medical products. These biologics are made up using variety of natural sources like human, animal or microorganisms. These biologics are like drugs. While some biologics are made with the intention of treating diseases and medical conditions, some other biologics can be used to prevent or diagnose diseases. Examples of biological products include

  1. vaccines
  2. blood and blood products for the purpose of transfusion and/or manufacturing into other products
  3. Allergenic extracts, widely used for both diagnosis and treatment. One example of allergenic extracts is the allergy shots.
  4. Human cells and tissues which are used for transplantation i.e. tendons, ligaments and bone etc.
  5. gene therapies
  6. cellular therapies
  7. certain tests used to screen potential blood donors for infectious agents such as HIV

Functions of CDSCO in regards of biologics are:

  • Human Vaccines (Bacterial, Viral and Combination Vaccine) Veterinary Vaccines – 

  1. Grant of NOC for manufacture of drugs for the purpose of Examination, test or analysis of vaccines.
  2. Approval of Clinical Trial.
  3. Grant of Marketing Authorization.
  4. Grant of Registration Certificate, Import License and Test Licence.
  5. Approval of Licensing (Vaccines) under CLAA Scheme.
  6. Issuance of Export NOC and Permission.
  7. Approval of Post Approval Changes
  • r-DNA Products – 

  1. Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of r-DNA products).
  2. Approval of Clinical Trial.
  3. Grant of Marketing Authorization.
  4. Grant of Registration Certificate, Import License and Test Licence in Form 11.
  5. Approval of Form 28-D Licensing (r-DNA) under CLAA Scheme.
  6. Issuance of Export NOC and Permission under Rule 37.
  7. Approval of Post Approval Changes
  • Stem based and cell-based products (Biological) – 

  1. Grant of NOC (manufacture of drugs for the purpose of Examination, test or analysis of Stem cells and Cell based products).
  2. Approval of Clinical Trial.
  3. Grant of Marketing Authorization.
  4. Grant of Registration Certificate, Import License and Test Licence.
  • Blood and blood products (Biological)

  1. Grant of NOC (manufacture of drugs for the purpose of Examination, test or analysis of Blood & Blood Products).
  2. Approval of Clinical Trial.
  3. Grant of Marketing Authorization.
  4. Grant of Registration Certificate, Import License and Test Licence.
  5. Approval of Licensing (Blood Products) under CLAA Scheme.
  • Veterinary Vaccines

  1. Grant of NOC for manufacture of drugs for the purpose of Examination, test or analysis of Veterinary vaccines.
  2. Grant of NOC for field trials.
  3. Grant of Marketing Authorization.
  4. Grant of Registration Certificate, Import License and Test Licence.
  5. Approval of Licensing (Veterinary Vaccines) under CLAA Scheme.
  6. Issuance of Export NOC and Permission.
  7. Approval of Post Approval Changes.

Cosmetics:-

In terms of Section 3 (aaa) of the Drugs and Cosmetics Act, 1940 "Cosmetics" means any substance intended to be anointed, poured, sprayed, or injected, or otherwise used, on the human body or in any part thereof to cleanse, beautify, enhance attractiveness, or to change the look and include anything intended to be used as part of cosmetics. ”

Under the provisions of the Drugs and Cosmetics Act, 1940 and its By-Laws, the manufacture of cosmetics is regulated by a system of testing and licensing by the State Government Licensed Authorities while the importation of cosmetics is regulated under the auspices of the State. The Drugs Controller General (India) acts as the Licensing Authority that issues registration and regulates the importation of cosmetics into the India vide Gazette notice G.S.R 426 (E) under the provisions of the Drugs and Cosmetics Act, 1940 and the laws made under it.

CDSCO’s Functions in Regards of Cosmetics Can be Termed as: 

  1. Amendment of Drugs and Cosmetics Laws, 1945 regarding the registration of importation of cosmetic products.
  2. Examination of applications relating to the registration of imported cosmetic products in accordance with the requirements of the Drugs and Cosmetics Act 1940 and the Regulations made under them.
  3. Assessment of various NOC applications / Specifications pertaining to the importation of cosmetic products.
  4. Correction of written responses to RTI, court cases, VIP references, and Parliamentary cosmetics-related questions.
  5. Respond to Government Letters / BIS where required.
  6. Management of PMOPGs / public inquiries/hearings related to the cosmetics registration process and provide guidance on it.
  7. Management of public / private / forums / forums / complaints regarding the quality of cosmetic products

Clinical Trials:-

Clinical trials are another aspect of the CDSCO. Clinical trial is also the most important aspect of CDSCO. Clinical trials mean trials for new drug before introducing them into the market for human consumption. CDSCO has been making every effort to make drugs safe for humans and animals. It is necessary as well because drugs can have a negative effect on health of general public. CDSCO provides clinical trials and global clinical trials. Functioning of the CDSCO in regards of clinical trials can be termed as:

  1. Processing of applications received for Global Clinical Trials
  2. Review and approval of Applications Licensing Licenses for the Import of Investigative Products (IMP) for Global Clinical Trials.
  3. Notification of Non-Interventional / Observation / Education / Investigator Notification Examination Notices.
  4. Review and approval of submission approval requests for submissions as major protocol amendments and changes to sponsors/applicant etc.
  5. Review of notices such as minor Protocol amendments, Investigator’s Brochure (IB), Informed Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), additions / site removal, Changes Chief Investigators / Investigators, Agreements Clinical, PI site ethics committee approval, Annual Status Reports, End of clinical trial notifications and Clinical Study Reports (CSR) etc.
  6. Complaints handling, parliamentary inquiries and RTI questions related to international clinical trials.
  7. Management / Monitoring of GCP Examination in accordance with case monitoring documents such as PSURs, ASRs, complaints received etc.
  8. Reviews and steps are taken in relation to GCP inspection reports received by the Inspection Team / Offender Offices (Cause notice, response to a notice of competitors, warning, retrenchment, suspension, etc.)
  9. Data-management management (receipts / files / other incorrect. Data including permissions made, archiving file / authorization files, parliamentary inquiries answered, CSR etc.) 

Conclusion

To conclude CDSCO is the authority that is responsible to prevent any mishappening in the field of medicines and medical equipment’s and the Government have been working very hard to make this authority work in a transparent and effective manner. And this authority is the need of the hour as India being a developing country and on its way to being specialized in the field of medicines and medical equipment’s have to prevent any harm as it would affect mass chunk of population dependant on the medical field.

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Author
Dheeraj Budhori
Dheeraj Budhori, an Internet Researcher & SEO, started his Optimizer journey in 2019. His top executive is his passion for search engine analysis & interest in understanding User psychology