2. Product Categories

Drugs
India

This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.

2.1 Category Name & Definition

Category Name

Drugs

Definition

"Drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of, specified in the First Schedule [1].

For the purpose of this Part, "new drug" shall mean and include:

1. A drug, as defined in the Act including bulk drug substance [or phytopharmaceutical drug] which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority.
2. A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form), and route of administration.
3. A fixed-dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of Appendix VI to Schedule Y.)  [1]

Specifications/Target Age

Target age is not specified for drugs under the Drugs and Cosmetics Act.  

Specifications for the 2 main classes of Drugs (Second Schedule of Drugs and Cosmetics Rules, 1945 [1]):

1. Drugs included in the Indian Pharmacopeia – Standards of identity, priority, and strength should comply with Indian Pharmacopeia. 
2. Drugs not included in the Indian Pharmacopeia but included in official Pharmacopeias of other countries - Standards of identity, priority, and strength should comply with other official Pharmacopeias.

Additional Information

"Drug" includes:

1. all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes;
2. 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;
3. all substances intended for use as components of a drug including empty gelatin capsules; and
4. such devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;                                                    

Current classification of medicines under the Drug and Cosmetic Act 1940 and Rules 1945 into Schedule G, H, H1, X under Rule 97. 

• Schedule G: Schedule G consists of drugs that can be administered only under the supervision of a Registered Medical Practitioner. 
• Schedule H: This schedule contains the list of the drugs to be sold by retail only in the prescription of a registered medical practitioner (RMP) 
• Schedule H1: This schedule contains the list of the drugs to be sold by retail only in the prescription of a registered medical practitioner (the pharmacist should maintain a register/record of all medicines sold). 
• Schedule K: consists of those drugs that are exempted from Chapter IV of the Drugs and Cosmetics Act of 1945 which deals with the manufacture, sale, and distribution of drugs and cosmetics. 
• Schedule X: consists of drugs which are required to be dispensed on prescription of Registered Medical Practitioners. It requires a special retail license to sell these medicines [1].

2.2 Product & Definition

N/A

2.3 References

1. THE DRUGS AND COSMETICS ACT, 1940 and THE DRUGS AND COSMETICS RULES, 1945 (As amended up to the 31st December, 2016

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf