It contains various rules and regulations for the manufacturing, waste disposal and equipment required for the manufacturing of drugs.
It has 10 parts, out of which the first part, Part 1 as a part of Good Manufacturing Practices (GMP), gives the general requirements for the manufacturing of drugs.
Parts I-A to I-E give the requirements for specific classes of drugs while Part I-F gives the requirements for the manufacture of bulk drugs/Active Pharmaceutical Ingredients (APIs).
Part II gives the equipment required for the manufacture of various classes of drugs.
Parts M-I, M-II and M-III give the requirements for manufacturing homeopathic medicines, cosmetics and medical devices respectively.
It states the requirements and guidelines for permission to import and/or manufacture drugs either for sale or to undertake clinical trials.
It was first drafted in 1985 after which the amendment took place in 2005.
Schedule Y (2005) has 3 sections and 11 appendices.
The 3 sections are:
Application for permission
Clinical Trial
Studies in Special Populations
The first section covers the information on data needed for a clinical trial application (CTA) and refers to relevant appendices for documents/data to be submitted.
The second section includes the processes and responsibilities of the various personnel and bodies involved in a clinical trial.
The third section covers the clinical trials in special sections of the population such as old people, children and pregnant women.
It also covers the BA/BE studies that are carried out.
Schedule Y has now been replaced with the New Drugs and Clinical Trial Rules (NDCT), 2019.
Schedule T gives the Good Manufacturing Practices (GMP) for Ayurvedic, Siddha and Unani medicines, the requirements for maintaining GMP for ASU drugs as well as the equipment needed for manufacturing them.
It has four parts out of which Part I gives the Good Manufacturing Practices (GMP) including the general requirements.
Part II is divided into subparts Part II-A, Part II-B and Part II-C which give the list of equipment required for the manufacture of Ayurvedic, Siddha medicines, Unani medicines and for in house quality control respectively.
If in a particular case, the Licensing Authority finds it necessary to modify the requirements, he/she can relax or alter them.
Schedule H is a class of 536 prescription drugs (as per the amendment to the Drugs & Cosmetics Rule in 2005) in India which appear as an appendix to the Drug and Cosmetics Rule, 1945.
Prescription drugs are those which cannot be purchased over the counter without the doctor’s prescription.
The labels of these drugs must prominently display the following texts:
“Rx” and
“Warning: To be sold by retail on the prescription of a Registered Medical practitioner only.”
If a Schedule H drug comes under the Narcotic Drugs and Psychotropic Substances Act, 1985 then it must prominently display the texts: “NRx” and “Warning: To be sold by retail on the prescription of a Registered Medical practitioner only.”
In 2013, another schedule called Schedule H1 was added to the Drugs and Cosmetics Rules, 1945 to control the indiscriminate use of antibiotics, anti-TB and some other drugs in India.
Similar to the drugs under Schedule H, these drugs cannot be sold without a valid prescription and the packaging of the drugs will have a warning printed in a box with a red coloured border.
