Table 13.

Legislation on pharmaceutical products in India, USA, and Europe.

Contents	India	USA	Europe
Governing authority	Central Drug Standard Control Organization (CDSCO) headed by Drugs Controller General of India (DCGI), Ministry of Health and Family Welfare, Government of India	Food Drug Administration (FDA)	European Union Regulatory Authority (EUMEA)
Rules and regulations	Drugs and Cosmetics Act, 1940 and Rules 1945—to regulate import, manufacture, licensing, testing, distribution, and sale of the drug in India. The Pharmacy Act, 1948—to regulate the pharmacy profession in India Drugs and Magic Remedies (Objectionable Advertisement) Act,1954	Food, Drug and Cosmetic Act (FD&C Act)	Directive 2001/82/EC (Veterinary medicinal products) Directive 2001/83/EC (medicinal products for human use)
Purpose	To regulate import, manufacture, distribution, sale, clinical trials, market authorization, and post-market surveillance of drugs in India	To regulate import, manufacture, distribution, and sale of drugs	Provides a legal framework for authorization, manufacture, and distribution of a drug in the EU
Drug	Chemical substance which alters the whole-body function and has the potential for misuse	Defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals”	Pharmaceutical preparations are defined as medicinal products consisting of active substances that may contain excipients, formulated into a dosage form suitable for the intended use
Additive/ Preservative	Any chemical or natural substance including fumigants capable of inhibiting or retarding the microbial growth	Any inactive fixings that are purposefully added to the therapeutic and diagnostic items, however it is not anticipated that they would apply remedial impacts at the planned dosage, regardless of the way that they may act to improve item delivery that presents well-being data concerning the correct and now proposed level of introduction, exposure time, or route of administration	Novel additives are described as the substances that are introduced for the first time in a formulation in addition to the active drug component or may be administered through a new route administration New additives are treated as a new entity or drug in the EU
Licensing/ Authorization	Required	Required	Required
Safety & management systems	Schedule M—GMP and requirement specifications of factory premises, plant and equipment for pharmaceutical products. Schedule T—GMP specifications for the manufacture of Ayurveda, Siddha, and Unani medicines. Schedule Y—specifications for clinical trials, import, and manufacture of new drugs	FDA issued guidelines for new additives entitled “Non-Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients” to establish the safety of dosage forms	IPEC Europe issued guidelines for evaluating the safety of new additives entitled “Guideline on additives in the dossier for application for marketing authorization of a medicinal product”. Documentation on every single novel additive is required on the principle of the CPMP Guideline (Chemistry of New Active Substances)
Regulatory aspects	GCP guidelines in accordance with WHO guidelines and ICH requirements for good clinical practices	FDA takes ICH safety testing direction papers for leading safety tests	European Medicines Agency (EMA) has established that pharmaceutical companies must follow GMP procedures to ensure the quality standards of medicinal products
References	[317,318]	[319,320]	[321,322,323]