Sector Specific Compliance:
Sector-specific compliance refers to the set of regulations and guidelines established by the Indian government to ensure that businesses operating within specific industries adhere to legal requirements, standards, and best practices. These regulations are tailored to address the unique characteristics, risks, and challenges of each sector. In India, various sectors such as banking, healthcare, telecommunications, pharmaceuticals, and environment have their own set of compliance requirements mandated by relevant regulatory authorities. These regulations encompass a wide range of areas including financial reporting, consumer protection, environmental sustainability, data privacy, safety standards, and more. Compliance with sector-specific regulations is essential for businesses to maintain legality, protect stakeholders' interests, and uphold industry standards while operating within the Indian market.
Healthcare Compliance:
Lets discuss the mandatory compliances and Licenses are required for healthcare in India:
Starting a business is tough, but they say if you have the guts to start, you have the guts to succeed. When starting a business or company, you need to get certain permissions, licenses, and follow various rules. These rules can differ based on factors like the amount of money you invest, the type of industry you're in, where your business is located, and how many people you employ. In India, if you want to start a healthcare company, you have to follow some mandatory rules and get specific licenses.
In India, the Ministry of Health and Family Welfare keeps an eye on the healthcare industry. The Directorate General of Health Services (Dte.GHS) is part of this ministry and handles technical knowledge about public health, medical education, and healthcare services.
To start a healthcare company in India, first, you need to register your business as a private company. You also need to register for taxes like service tax and GST.
The Pharmaceutical industry is one of the areas that come under the ambit of healthcare compliances and is extensively regulated by the following:
- Central Drugs Standard Control Organization (CDSCO):
The Central Drugs Standard Control Organisation (CDSCO) is India's main regulatory body for cosmetics, pharmaceuticals, and medical devices. It's like India's version of the FDA in the US or the European Medicines Agency in the EU. The Indian government plans to review all medical devices, including implants and contraceptives, under the CDSCO.
Within the CDSCO, the Drug Controller General of India (DCGI) oversees pharmaceuticals and medical devices. It's part of the Ministry of Health and Family Welfare. The DCGI gets advice from the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
The CDSCO has different offices in zones. Each one checks before and after a license is given, watches the market after a product is out, and recalls drugs if needed. Manufacturers who work with the CDSCO need to choose an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India. CDSCO issues various certifications for pharmaceuticals, medical devices, and cosmetics:
A. Drug Manufacturing License: A Drug Manufacturing License in India is a legal requirement for companies engaged in the production of pharmaceutical products. It signifies that the manufacturing facilities meet the necessary standards and regulations set forth by the Central Drugs Standard Control Organization (CDSCO). This license is essential to ensure the quality, safety, and efficacy of pharmaceuticals produced in India. Without this license, companies are not permitted to manufacture drugs for distribution or sale in the country.
- An Import License issued by the Central Drugs Standard Control Organization (CDSCO) in India is mandatory for companies intending to import drugs or medical devices into the country. This license ensures that the imported products comply with the quality standards set by CDSCO for their respective categories. It serves as a regulatory measure to safeguard public health by ensuring that only safe and quality products enter the Indian market. Without an Import License from CDSCO, companies are prohibited from importing drugs or medical devices into India for distribution or sale.
B. Medical Device Registration: In India, the registration of medical devices is regulated by the Central Drugs Standard Control Organization (CDSCO), under the provisions of the Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017. The CDSCO is responsible for ensuring the safety, efficacy, and quality of medical devices available in the Indian market.
4. Clinical Trial Approval: In India, the conduct of clinical trials is regulated by the Central Drugs Standard Control Organization (CDSCO) under the provisions of the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules, 2019. CDSCO ensures that clinical trials are conducted ethically, with due consideration for patient safety and data integrity.
- Indian Council for Medical Research (ICMR):
The Indian Council of Medical Research (ICMR) primarily oversees and regulates biomedical research in India, including the approval of various registrations and licenses related to research activities. Some of the key registrations and licenses approved by ICMR in India include:
A. Institutional Ethics Committee (IEC) Registration: ICMR mandates that all institutions involved in biomedical research, including hospitals, universities, and research organizations, establish an Institutional Ethics Committee (IEC) to review and approve research protocols involving human participants. ICMR provides registration and oversight for these committees to ensure compliance with ethical guidelines and protection of participants' rights and welfare.
B. Biomedical Research Registration: ICMR requires researchers and institutions to register their biomedical research studies with the National Institutes for Health (NIH) Clinical Trials Registry India (CTRI). This registration ensures transparency and accessibility of research information to the public, healthcare professionals, and regulatory authorities.
C. Biological Material Transfer Agreements (MTAs): ICMR facilitates the approval of Biological Material Transfer Agreements (MTAs) between institutions and researchers for the exchange of biological materials such as samples, reagents, and cell lines. These agreements outline the terms and conditions governing the transfer, use, and sharing of biological materials while ensuring compliance with ethical, legal, and regulatory requirements.
D. Biomedical Waste Management License: ICMR collaborates with regulatory bodies such as the Central Pollution Control Board (CPCB) and State Pollution Control Boards (SPCBs) to regulate the management and disposal of biomedical waste generated during research activities. Institutions conducting biomedical research must obtain licenses and comply with guidelines for the safe handling, segregation, treatment, and disposal of biomedical waste to prevent environmental contamination and public health risks.
3. Drugs Controller General of India (DCGI):
The Drug Controller General of India (DCGI) is a key authority in the pharmaceutical sector, overseeing various matters including product approval, clinical trials, introduction of new drugs, and enforcement of drug regulations.
All drugs must be sold under license. The Drugs and Cosmetics Act, 1940 specifies that certain drugs can only be sold with a prescription from a registered doctor. The Drugs and Magic Remedies Act, 1954 regulates advertising to medical practitioners and chemists, requiring specific disclaimers on promotional materials. The Pharmacy Act, 1948 governs the pharmacy profession, while the Clinical Establishments (Registration and Regulation) Act, 2010 mandates registration and regulation of clinical establishments, setting minimum standards
The Drug Controller General of India (DCGI) oversees the regulation and approval of drugs, vaccines, medical devices, and clinical trials in India. Various registrations and licenses approved by DCGI include for facilities and services.
- Manufacturing License: Manufacturers of drugs, vaccines, and medical devices must obtain a manufacturing license from DCGI to produce and distribute these products within India. The manufacturing facilities are subject to inspection and compliance with Good Manufacturing Practices (GMP) guidelines to ensure quality and consistency in production processes.
- New Drug Approval: DCGI evaluates applications for the approval of new drugs and fixed-dose combinations based on their safety, efficacy, and quality data. The approval process involves a comprehensive review of preclinical and clinical studies, manufacturing processes, and regulatory documents to assess the product's benefit-risk profile and suitability for marketing in India.
- Marketing Authorization: Before a drug, vaccine, or medical device can be marketed or sold in India, it must receive marketing authorization from DCGI. This involves the submission of a detailed application dossier containing preclinical and clinical data, manufacturing information, and regulatory documents to demonstrate the product's safety, efficacy, and quality.
Mandatory Acts and Rules:
The Drugs and Cosmetics Act, 1940 is a significant legislation in India governing the manufacture, sale, and distribution of drugs and cosmetics. Enacted to ensure the safety, efficacy, and quality of pharmaceuticals and cosmetic products, this act provides a comprehensive regulatory framework for the pharmaceutical industry.
The act mandates that manufacturers, distributors, and sellers of drugs and cosmetics obtain appropriate licenses from regulatory authorities to ensure compliance with quality standards and regulations.
It establishes standards for the quality, purity, and potency of drugs and cosmetics, thereby safeguarding public health and consumer interests. The act regulates the import and export of drugs and cosmetics to ensure adherence to quality standards and prevent the entry of substandard or counterfeit products into the market. Certain drugs deemed harmful or hazardous to public health are prohibited under the act, and their manufacture, sale, or distribution is strictly regulated or banned. The act specifies that certain drugs can only be sold or dispensed with a valid prescription from a registered medical practitioner, thereby controlling the misuse and abuse of prescription drugs.
The Pharmacy Act, 1948 is a significant legislation in India governing the pharmacy profession and the regulation of pharmacy education and practice. Enacted to ensure the quality and standards of pharmacy services, this act provides a comprehensive regulatory framework for
Pharmacists and pharmaceutical institutions across the country.
The act mandates the registration of pharmacists with the respective State Pharmacy Councils (SPCs) or the Pharmacy Council of India (PCI). Registration is essential for individuals to practice pharmacy legally in India. The act regulates the education and training of pharmacists by prescribing the minimum qualifications and standards for pharmacy courses and institutions. It ensures that pharmacists receive adequate training to meet the evolving needs of the healthcare sector. The act outlines the duties and responsibilities of pharmacists in dispensing drugs, maintaining pharmacy records, and ensuring patient safety. It also sets standards for the storage, distribution, and sale of drugs in pharmacies. The act establishes a code of ethics for pharmacists, emphasizing professional integrity, confidentiality, and patient care. Pharmacists are required to adhere to ethical principles in their practice and maintain the highest standards of professionalism. The act empowers the SPCs and PCI to take disciplinary action against pharmacists found guilty of professional misconduct or negligence. Disciplinary measures may include suspension or cancellation of registration, fines, or other penalties
The Clinical Establishments (Registration and Regulation) Act, 2010 is a significant legislation in India aimed at improving the quality and standards of healthcare services provided by clinical establishments across the country. Enacted to ensure patient safety and regulate the functioning of healthcare facilities, this act provides a framework for the registration, regulation, and maintenance of standards in clinical establishments.
The act mandates the registration of all clinical establishments, including hospitals, clinics, diagnostic centers, and laboratories, with the appropriate regulatory authority. Registration is essential to ensure compliance with quality standards and regulations. The act prescribes minimum standards for infrastructure, equipment, personnel, and services provided by clinical establishments. It aims to ensure that healthcare facilities meet the necessary requirements to deliver safe and effective patient care. The act regulates clinical practices, including medical procedures, diagnostic tests, and treatment protocols, to safeguard patient interests and promote evidence-based healthcare practices.
Article written by
Ayush Gupta, an legal intern at Corpzo
