MINISTRY OF HEALTH AND FAMILY WELFARE ﴾Department of Health﴿ updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act.

It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y. Different type of forms are also given for different type of approvals from drug authorities. Following are the schedules:

Schedule A: Forms and applications

Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories

Schedule C: Biological and Special Products

Schedule C﴾1﴿: Other Special Products

Schedule D: Class of Drugs: Extent and conditions of exemption

Schedule D﴾I﴿: Information and undertaking required to be submitted by the manufacturer of his authorized agent with the application form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a computer floppy.

Schedule D﴾II﴿: Information required to be submitted by the manufacturer or his authorized agent with the application form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a computer floppy.

Schedule E: Omitted

Schedule E﴾1﴿: List of Poisonous Substances under the Ayurvedic ﴾including Siddha﴿ and Unani Systems of Medicine

Schedule F: Part I to Part XII‐A – Omitted
Part XII‐B: Requirements for the functioning and operation of a Blood Bank and / or for preparation of Blood Components
﴾I﴿ Blood Banks / Blood Components
﴾II﴿ Blood Donation Camps
﴾III﴿ Processing of Blood Components from whole blood by a Blood Bank
Part XII‐C:
﴾I﴿ Requirements for manufacture of Blood Products
﴾II﴿ Requirements for manufacture of Blood products from bulk finished products
Part XIII: General Schedule F﴾I﴿: Part I: Vaccines
﴾A﴿ Provisions applicable to the production of Bacterial Vaccines
﴾B﴿ Provisions applicable to the production of Viral Vaccines
Part II: Antisera
Provisions applicable to the production of all sera from living animals
Part II: Diagnostic Antigens
Provisions applicable to the manufacture and standardization of Diagnostic Agents ﴾Bacterial Origin﴿
Part IV: General

Schedule F﴾II﴿: Standards for Surgical Dressings Schedule F﴾III﴿: Standards for umbilical Tapes Schedule FF: Standards for Ophthalmic Preparations Schedule G:

Schedule H: Prescription Drugs

Schedule I: Omitted

Schedule J: Disease and ailment ﴾by whatever name described ﴿ which a drug not purport to prevent or cure.

Schedule K: Class of drug: Extent and conditions of exemption

Schedule L1: Good Laboratory Practice

Schedule M: Good manufacturing practices and requirements of premises, plant and equipment for Pharmaceutical product.
Part I: Good manufacturing practices for premises and materials.
Part I‐A: Specific requirements for manufacture of sterile products, parental preparation ﴾small volume injectables and large volume parental﴿ and sterile ophthalmic preparation.
Part I‐B: Specific requirement for manufacturing of oral solid dosage forms ﴾Tablet and Capsules﴿.
Part I‐C: Specific requirement for manufacture of oral liquids ﴾Syrup, elixirs, emulsions and suspensions﴿.
Part I‐D: Specific requirements for manufacture of topical products i.e. external preparation ﴾creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products﴿
Part I‐E: Specific requirements for manufacture of metered‐dose‐inhalers ﴾MDI﴿
Part I‐F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ﴾ Bulk Drugs ﴿.
Part II: Requirements of plant and equipment.
Schedule M‐I: 1. Requirements of factory premises for manufacture of homoeopathic preparations.
                        2. Requirements of plants and equipments.
Schedule M‐II: Requirements of factory premises for manufacture of cosmetic.
Schedule M‐III: Requirements of factory premises for manufacture of medical devices.
Part I‐B: Specific requirement for manufacturing of oral solid dosage forms ﴾ Tablet and Capsules ﴿.
Part I‐C: Specific requirement for manufacture of oral liquids ﴾ Syrup, elixirs, emulsions and suspensions﴿.
Part I‐D: Specific requirements for manufacture of topical products i.e. external preparation ﴾ creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products ﴿
Part I‐E: Specific requirements for manufacture of metered‐dose‐inhalers ﴾MDI﴿
Part I‐F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ﴾ Bulk Drugs ﴿.
Part II: Requirements of plant and equipment.

Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy

Schedule O: Standard for Disinfectant Fluids

Schedule P: Life Period of Drugs

Schedule P1: Pack Sizes of Drugs

Schedule Q: List of Dyes, colours and Pigments permitted to be used in Cosmetics and Soaps as given under IS : 4707 ﴾Part I﴿‐1988 as amended by the Bureau of Indian Standards

Schedule R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives

Schedule S: Standard for cosmetics.

Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.

Schedule U: I – Particulars to be shown in the manufacturing records.
                    II – Records of Raw Materials.
                   III – Particulars to be recorded in the analytical records.

Schedule U﴾I﴿: I – Particulars to be shown in manufacturing records.
                        II – Records of Raw Material.

Schedule V: Standards for patent or proprietary medicines.

Schedule W: Omitted

Schedule X

Schedule Y: Requirements and guidelines for permission to import and/or manufacture of New Drug for sale or to undertake clinical Trials.