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How to Establish Homeopathic Laboratory in India

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Introduction: Homeopathic Laboratory

The Central Council for Research in Homeopathy, an apex research institute under the Ministry of AYUSH, Govt. Of India, which undertakes, Coordinates, develops, disseminates, and promotes scientific research in Homeopathy. The Headquarters of the Council is situated in New Delhi, and the Institute has taken several steps for the development and promotion of Homoeopathy manufacturing and laboratory establishment.

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Under the National AYUSH Mission (NAM), the Ministry of AYUSH is responsible for centrally sponsored Schemes of the National AYUSH Mission (NAM) through States/UTs for the promotion and development of AYUSH systems of Medicine including Homoeopathy. Even State/UT governments can avail of financial assistance after the submission and qualification of the proposal as per the NAM guidelines through the State's Annual Action Plans (SAAPs). The plans of the AYUSH systems including Homoeopathy are:

  • Co-location of AYUSH facilities including Homoeopathy at Primary Health Centers (PHCs), Community Health Centers (CHCs), and Districts Hospitals (DHs) Supply of Essential drugs of Homoeopathy to AYUSH hospitals and dispensaries.
  • Upgradation of existing State Government AYUSH Homoeopathy Hospitals and Dispensaries, the establishment of Institutions, dispensaries, and Health Centers.

The Ministry of AYUSH has repealed the Homoeopathy Central Council Act, 1973 dated July 5th, 2021, and constituted National Commission for Homoeopathy, to exercise the power and function assigned to it under the National Commission for Homoeopathy Act, 2020.  

The Department of Science and Technology (DST) is the nodal department for organizing, coordinating, and promoting scientific and technological activities throughout the Country and expanding this to new areas of research in the field. It handles matters related to the Scientific Advisory Committee of the Cabinet (SACC) and promotes new areas of research in Laboratories, and coordinates across several departments.

Background

The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) is an office under the Ministry of AYUSH, for the Development of Pharmacopoeias and Formularies as well as acting as Central drug testing cum Appellate Laboratory for Indian Systems of Medicine & Homoeopathy.

For the establishment of a Manufacturing, and testing laboratory, a Pharmaceutical License is required for all business activities involved in the Manufacturing, and distribution of Medicines & pharmaceutical supplements.  Section 3(b) of the Drugs & Cosmetics Act, of 1940 comprises all devices & medications for humans, animals as well as all habitats with the aim to mitigate, treat, diagnose, or prevent the disorder or disease. For the manufacturing of any type of Homoeopathic drugs including Ayurvedic & Unani Drugs, licensing is mandatory to do business in the area of drugs & Cosmetics in India. 

The licensing procedure is governed by the State government, so even if a person is operating their business in one state and willing to be operational in another state need to obtain another certification from the concerned authorities of that state as well.  Hence the Manufacturing, selling, wholesaling, distribution, retailer, and importers of cosmetic products, and homeopathy drugs have to compulsorily take permission under the Drugs and Cosmetics Act, of 1940.

Who Are The Authorized Person For The Business Of Laboratory Pharmacy

  • Pharmaceutical Proficient or a Pharmacist
  • Expert Staff 
  • Technical expert

Licenses Required For The Establishment Of Homeopathic Laboratories In India

Government institutions authenticate projects and businesses, and pathology labs that play a very sensitive part in people's lives before granting the license to the licensee.

The following are the licenses required to set up the laboratory:

National Accreditation Board Requirement for Testing and Calibration Laboratories (NABL) Accreditation

The National Accreditation Board for Testing and Calibration Laboratories is a reputable government agency that works with other regulatory agencies like APEDA, FSSAI, EIC, and others to streamline the recognition process from various Certification bodies so that they can cooperate at a single combined assessment rather than separate assessments. The laboratory equipment is recognized as legitimate thanks to the NABL certification, so the patient has faith in the technicians doing the tests.

Read Our Blog: National Accreditation Board of Testing and Calibration Laboratories

The NABL accreditation enables one to be recognized as an International Laboratory Accreditation Cooperation (ILAC) MRA in markets around the world where the ILAC MRA is in effect. The International Laboratory Accreditation Cooperation (ILAC) Arrangement or Mutual Recognition Arrangement (MRA) symbol recognizes NABL as a full-time member.

With the help of this system, traders might operate more cheaply and easily on a worldwide scale. The NABL ensures that the technology being utilized is of National Standard and can effectively meet the standards. It verifies that the technological measures being adopted for the laboratory that is being established are accurate.

A mutual recognition agreement exists between the NABL and the Asia Pacific Laboratory Accreditation Cooperation.

Procedure for NABL certification 

  • File Application for accreditation
  • Acknowledgment by authority (NABL)
  • Document review
  • Pre-assessment of CAB
  • Final assessment of CAB accreditation
  • Scrutiny by the assessment report
  • Recommendation for accreditation
  • Approval for accreditation
  • Issue of accreditation certificate 

For getting information about the procedural aspects of getting certification; follow the page through the link NABL Approval for Lab 

What Is The Legal Procedure That Needs To Be Followed For Establishing A Homoeopathic Laboratory In India? 

The organization in charge of accrediting and registering laboratories that fall under the purview of the Department for the Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India, is known as the National Accreditation Board for Testing and Calibration Laboratories (NABL). Laboratory and other scientific and technology-related facilities are evaluated for competence and quality by NABL. It makes it possible for the provider of proficiency testing to be recognized for operating in accordance with international standards and for possessing technical competencies relevant to all testing schemes. It guarantees that there is little likelihood that the laboratory will measure false data because it demonstrates expertise in all technical areas.

What Documents Are Required 

The applicant laboratory must send NABL five copies of the application and five copies of the quality manual. To ascertain whether the Quality Manual conforms with the requirements of ISO 15189 the NABL will send it to a Lead Assessor. The next day, the Lead Assessor will perform a Pre Assessment of the laboratory. Based on the lab may note on the Pre-Assessment report that certain remedial actions must be taken in order to be fully prepared for the evaluation. Depending on the needs of the laboratory, the project's goal, the entire assessment technique being used, and other factors, the NABL may demand different documentation for different projects. Nonetheless, the typical documents that must be kept on hand while filling out the form are as follows:

  • Objectives of the establishment
  • Policies and procedures are part of standard operating procedures (SOP).
  • Device manuals
  • Form checklists
  • Document Formats

Contact us for more information if you need it for certification of the same.

Governing body for the production of drugs 

The Indian government oversees the system for granting drug licenses to manufacturers, laboratories, pharmacies, etc. India's licensing process is governed by the Drugs and Cosmetics Act of 1940. The following categories further split the licensing authorities:

  • Standard Control Organization for Central Drugs (CDSCO)

The Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, oversees the operations of the Central Drugs Standard Control Organization. The CDSCO has authority and responsibility under the 1940 Pharmaceuticals and Cosmetics Act for the licensing and approval process of newly developed drugs and other associated services. The CDSCO is the regulatory body for the procedure of import of quality drugs and coordination with the SDSCO.

  • State Drugs Standard Control Organization (SDSCO)

The State Drugs Standard Control Organization Control and regulate the Licensing mechanism for the Manufacturing, sales, and distribution of drugs under the authority of CDSCO.

How To Apply For A License From SDSCO To Operate A Homeopathy Manufacturing Pharmacy

All types of pharmaceuticals, including Ayurvedic, cosmetics, and allopathic ones, must be manufactured in compliance with the 1940 Drugs and Cosmetics Act, which necessitates the acquisition of a Manufacturing Drug License. The state government in which the Project will be established handles licensing. The procedures listed below must be followed:

  • Visit the Ayush portal or the relevant State Drug Standard Control Organization's (SDSCO) website in accordance with the license you need;
  • Sign up for an account on the website, log in, and fill out the application with the license you need and the relevant department.
  • The applicant must complete the application form, upload the necessary documents (please double-check that all of your documents comply with the requirements before submitting), and pay the needed price.
  • The application is sent to the regional department that is responsible, and the drug inspector looks it over before visiting the location to confirm the information.
  • The license is finally issued after the inspection is over.

Forms Required for Filling out The Application for Homeopathic Pharmacy

  • Form 24: The form is available either for the grant of a License for the Manufacture or distribution of drugs or for renewal of a license other than those defined under Schedule C, C (1), and X.
  • Form 24A: The application is available for the grant of a loan license for the manufacture or sale of drugs, other than those defined under Schedule C, C(1), and X.
  • Form 24C: the application is available for the Manufacturing for sale, distribution of Homeopathic medicine, or licensing to manufacture potential preparation from back potency by the Owner of a license under Form 20-C.
  • Form 24D: the application for the grant of license to manufacture Ayurvedic, Siddha, or Unani Drugs. 
  • FORM 24E: Application for the grant of or renewal of loan License to manufacture for sale of Ayurvedic, Siddha, or Unani drugs.
  • Form 24F: the application for grant or renewal of Manufacturing license for sale or distribution of Drugs of schedule X and not specified in Schedule C and C(1).
  • Form-19-B: the application for the licensing agency designated by the concerned State Government.

Documents Required For Filling Out The Application To The State Drugs Controller

  • Cover letter(describing the experience and qualification of the applicant);
  • Form 19-B for (drug licensing)
  • ID card of the applicant (Director, Proprietor, Partner);
  • A detailed plan of the site (layout dimensions);
  • Proof of Storage and equipment;
  • Establishment certificate i.e. MOA (memorandum of understanding), AOA(Articles of Association), LLP, partnership deed;
  • Copy of the Board Resolution along with the consent for licensing;
  • The affidavit of the Competent person;
  • The Ownership documents (rent agreement along with NOC from owner, Ownership letter) ;
  • Applicant Qualification Certificate (experience certificate, letter of approval, affidavit, report of Employers, and staff)
  • Affidavit of the applicant;
  • Authorized Signature of the applicant

Conclusion

You can apply at the licensing authority designated by the concerned State Government after meeting all conditions. After receiving your application, an AYUSH officer will visit your location and, if all requirements are met, grant you a production license. If not, the file will be sent for correction. The NABL plays an important role in the establishment of and growth of the industry.

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This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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Author
Sagar Sharma
I have over 8 years of experience working in product regulatory compliance. Currently, I work as the operations head at Corpseed Ites Pvt Ltd, where my Job role is providing best in class consulting in the field of product compliance.

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