Table of Contents
Manufacture of drugs
The manufacture of drugs is a critical process that plays a crucial role in the healthcare industry. From the development of new medications to the production of existing drugs, this process ensures that patients have access to safe and effective treatments.
Manufacture in relation to any drugs or cosmetic includes any process or part of process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drugs or cosmetics for sale or distribution but doesn’t include compounding or dispensing any drug.
Prohibition of manufacture and sale of certain drugs.
The following categories of drugs and cosmetic are prohibited to be manufactured or sold:
1. Any drug our cosmetics which is substandard, misbranded and adulterated.
2. Any patient or proprietary medicine without clear induction of ingredients.
3. Any drug claiming for accurate cure or prevention of disease listed in schedule T.
4. Manufacturing for sale of any drugs are cosmetics containing any harmful ingredients.
5. Any manufacturing of formulation containing drug or cosmetic, which has been imported into our country in contravention to the provision of the expander rules.
Criteria for manufacture of drugs
There are several types of licenses, which is required for manufacturing:
1. License for manufacture of schedule C & C1
- These are some conditions to be fulfilled for mfg. of drug specified in C &C1:
- Drug must be issued in previous sterile shield glass water or suitable container.
- Container should comply with requirement of schedule F.
- Drug must comply with standard of schedule F.
- Serum tested for freedom from abnormal toxicity, multidose container for liquids should contain.
- Parental in dose of 10 ml or more should be tested for freedom from pyrogens.
- Separate lab for culture and manipulation of spore bearing pathogens.
- A license is obtained from licensing authority on application in prescribed form no. 7 with prescribed fees.
- Licensed premises must conform to the requirements of GMP specified in schedule M.
- The license must provide adequate arrangement for testing the strength & quality of drugs.
2. License for manufacture of schedule X drugs
General conditions are same as other, additional condition for this:
- Account of all transactions regarding manufacture should be maintained in a serially bound and paged register.
- Manufacture is required send the copies of invoice of sale/manufacture of drugs to licensing authority in every three months.
- Preparation should be labelled as X.
- No should X drugs should be supplied by the way of physician sample.
- Drugs specified in schedule X drugs shall be marketed in packing not more than 100-unit dose – tablet/capsule, 300 – oral liquid and 5ml – injection.
3. License for manufacture of drugs other than those specified in C & C1, X
- A license is obtained from license authority on application in prescribed form no. 24 with prescribed fees.
- If conditions are fulfilled than license is issued in prescribed form no. 25.
- Maintain an inspection book in which inspector may record their interferences.
- License must provide any additional requirement as directed by authority.
- License must furnish the data of stability of drugs if demanded.
4. Manufacture of drugs for test, examination and analysis
Required following conditions:
- The license is obtained from licensing authority by form no-29.
- License must use manufactured drugs exclusively for the purpose for which they are manufactured.
- Must maintain the records of the manufactured drugs, showing their quantity & name of the persons to whom they have been supplied.
- Maintain inspection book.
- License must comply with such additional requirements of which he has been given at least 1-month notice by the license authority.
- Others same as general conditions.
5. Manufacture of new drugs
In addition to provisions for manufacture of drugs, there should be documentary evidence for quality, purity, therapeutic trials of new drugs and evidence for approval under schedule ‘Y’.
6. Loan license
A license issued by the licensing authority to an applicant who does not have its own arrangement for manufacture but who intends to avail himself of the manufacturing facilities owned by another license.
The general conditions are same as other and the addition conditions are:
- Application must be supported by patent firm.
- Drugs inspector inspects the premises of parent firm.
- The license must test each batch of raw material and finished product.
- The production must be supervised by competent person of loan license.
7. Repacking license
- Process of breaking up any drug from its bulk container into small package and labelling with a view to their sale and distribution is fine under repacking license.
- Application is made for grant and renewal of license in form 24-B.
- The license is issued by licensing authority after inspection in form 25-B.
8. Conditions for repacking license
- Requirement of GMP for repacking specified in schedule M.
- General conditions are same as other.
- Repacking should be supervised by competent v persons.
- There should be adequate arrangement for testing of samples.
- The license should be kept on the license premises & should produce before an inspector on demand.
- License should comply with the provision of the act.