Drugs and Cosmetics Act and Rules Licence to Manufacture Drugs:

• 1. Licence to manufacture drugs other than those specified in Schedule C & C1 and Schedule X.

• 2. Licence to manufacture drugs specified in Schedule C and C1

• 3. Licence to manufacture drugs specified in Schedule X

• 4. Loan licence and

• 5. Repacking licence.

MANUFACTURE OF DRUGS

“Manufacture” includes any process or part of a process to make, alter, ornament, finish, pack, label, break up or otherwise treat any drug or cosmetic with a view to its sale or distribution. It does not include to compound or dispense of any drug.

A licensing authority appointed by the state government issues licenses to manufacture drugs and cosmetics. The Drugs and Cosmetics Rules 1945 mention the following categories of license to be issued by the licensing authority

• 1. Form 24-A: Rule 69-A: Application for grant or renewal of a loan license to manufacture for sale or for distribution of drugs other than those specified in Schedules C, C(1), and X

• 2. Form 24-B: See Rule 69: Application for grant or renewal of a license to repack for sale or distribution of drugs, being drugs other than those specified in Schedules-C and C(1) excluding those specified in Schedule-X

• 3. Form 24-F: Rule 69: Application for the grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C (1)

• 4. FORM 25: Licence to manufacture for sale or distribution of drugs other than those specified in Schedules C, & C(1) and Schedule X

• 5. FORM 25-A: Loan licence to manufacture for sale or distribution of drugs other than those specified in Schedules C, & C(1) and Schedule X

• 6. FORM 25-B: Licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C(1) excluding those specified in Schedule X

• 7. FORM 25-F: Licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C & C(1)

• 8. FORM 26: Certificate of renewal of a license to manufacture for sale of drugs other than those specified in Schedule X

• 9. FORM 26-A: Certificate of renewal of loan license to manufacture for sale of drugs other than those specified in Schedule X

• 10. FORM 26-B: Certificate of renewal of a license to repack for sale or distribution of drugs other than those specified in Schedules C and C(1) excluding those specified in Sch. X

• 11. FORM 26-F: Certificate of renewal of a license to manufacture for sale of drugs specified in Schedule X

• 12. FORM 27: Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding that specification in Part XB and Sch. X

Above said licenses issued through different forms can be summarised below

• 1. Licence to manufacture drugs other than those specified in Schedule C & C1 and Schedule X.

• 2. Licence to manufacture drugs specified in Schedule C and C1

• 3. Licence to manufacture drugs specified in Schedule X

• 4. Lon licence and

• 5. Repacking licence.

License to manufacture drugs other than those specified in Schedule C & C1 and Schedule X.

Application for grant of license manufacture drugs other than those specified in Schedule C & C1 and Schedule X shall be submitted in form 24 under Drugs and Cosmetics Rules 1945 to licensing authority appointed by the state government. The application shall include the name of drugs not more than 10 for each category of drugs. A license fee of Rs 600/- (Rs Six hundred only) and an inspection fee of Rs 1500 for every inspection shall also be submitted with the application.

The licensing authority issues a license in form 25 after following the due procedure for licensing.

These fees are applicable both to grant a license or to renew a license. If an application to renew is submitted after the expiry of the license and within six months of the expiry period then an additional fee of Rs 1000/- (Rs One thousand only) shall also be deposited along with the license fee and inspection fee.

Conditions for the grant or renewal of a license in Form 25: Rule 71 of the Drugs and Cosmetics Act states the following conditions to be followed by the licensee.

• 1. The manufacturing unit shall provide premises that comply with all conditions prescribed in schedule M (Good Manufacturing Practices: GMP) of drugs and cosmetics rules.

• 2. Applicant shall provide adequate staff, premises, and laboratory equipment to carry out quality control tests. The testing unit shall be separate from the manufacturing unit. Both units shall have independent heads.

• 3. The head of the testing unit shall have a degree in pharmacy, pharmaceutical science, medicine, or science from a recognized university. Adequate duration of experience in testing and analysis of drugs. Duration of experience shall be fixed by licensing authority that may vary from state to state.

• 4. Manufacturing of drugs shall be carried out under the direct personal supervision of competent technical staff.

• 5. Qualification of competent technical staff shall be

  • · Graduate in pharmacy or pharmaceutical chemistry from a recognized university with eighteen months practical experience in manufacturing of drugs after completion of his graduation. However person can undergo practical training for 6 months during his/her graduation. This six-month duration of training shall be reduced from 18 months of training after completion of graduation.

  • · Graduate in science with chemistry as a principal subject from a recognized university. He/she has practical training experience of not less than three years in the manufacturing of drugs after completion of graduation.

  • · Graduate in chemical engineering, chemical technology, or medicine from a recognized university. He/she has practical training experience of not less than three years in the manufacturing of drugs after completion of graduation.

  • · Holding any foreign qualification equivalent to any one of the above-mentioned qualifications and permitted by the central government to work as a competent person under the Drugs and Cosmetics Act.

  • · For drugs other than those specified in Schedule C & C1 and Schedule X to be manufactured for veterinary purposes, the qualification of competent staff shall be a Graduate in Veterinary Science or General Science or Medicine from a recognized university with not less than three years practical experience to manufacture such drugs after completion of the degree program. Or graduate in pharmacy from a recognized university with at least eighteen months of practical training and experience to manufacture such drugs after completion of the degree program.

  • · Above said qualifications shall not be essential for competent staff to manufacture disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of Paris, and surgical dressings. Qualifications and experience shall be decided by the licensing authority.

• 6. Applicant shall have adequate facility to store drugs manufactured in licensed premises

• 7. Applicant applying to manufacture patent and proprietary medicine shall furnish the following data evidence to justify that patent and proprietary medicines

  • · contain ingredients in quantity to be used for therapeutic purpose

  • · Vehicles, additives, and pharmaceutical aids are for pharmaceutical purposes and safe for use

  • · Stable in recommended storage conditions.

  • · Contain active ingredients with therapeutic justification

  • · have approval in favor of the applicant to manufacture drug formulation under the category of a new drug.

• Duration of license: Rule 72 of the drugs and cosmetics rules states that license or renewal of license shall remain valid for five years from the date of manufacturing or date of renewal.

• The renewal application shall be submitted before the expiry of the license or within six months from the date of expiry. If applied for renewal after the expiry of license then the applicant shall also deposit an additional fee. After the application is submitted for renewal, the license shall remain valid till further order from the licensing authority.

• A renewal license shall be issued in form 26 under rule 73 of the drugs and cosmetics rule.

Licensee shall further comply with the following conditions mentioned in rule 74 of the drugs and cosmetics rules

• 1. The licensee shall test or analyze each batch of raw materials to be used in manufacturing and each batch of the final product.

• 2. The licensee shall maintain a record/register of manufacturing, testing, and analysis showing all particulars specified in Schedule U of the Drugs and Cosmetics Rules. The record shall be maintained for 5 years from the date of manufacturing

• 3. The licensee shall allow the authorized drug inspector to inspect licensed premises about staff employed, equipment and facility available for manufacturing and analysis, registers and records maintained, etc.

• 4. Authorised drug inspectors can take samples of drugs manufactured on premises for testing and analysis.

• 5. The licensee shall maintain an inspection book in form 35.

• 6. Licensing authority may stop the marketing of drugs of any batch on a valid ground. If that drug is already in the market for sale then the licensee shall withdraw it from the market.

• 7. The licensee shall inform the licensing authority if there is any change in competent technical staff to manufacture and analyze work.

• The licensee shall maintain reference samples from each batch. Quantity of samples shall be twice the requirement to perform the test and analysis of samples. The sample shall be stored for at least for next three months from its expiry date. If there is no expiry date then the sample shall be kept for three years from its date of manufacturing.

Alok Bains

License to Manufacture Drugs to sell and distribute Specified in Schedule C and C1

Application is submitted in form 27 for a license to manufacture drugs. The application shall not contain names of more than ten drugs from each class. The application shall be submitted with a license fee of Rs 600/- (Rs six hundred only) and an inspection fee of Rs 1500/- (Rs One thousand Five hundred) for each inspection. These fees are applicable both to grant a license or to renew a license.

• If an application to renew is submitted after the expiry of the license and within six months of the expiry period then an additional fee of Rs 1000/- (Rs One thousand only) shall also be deposited along with the license fee and inspection fee.

• Licensing authority issues licenses in form 28 to manufacture drugs specified in Schedule C and C1 for sale and distribution. This license shall not include the manufacturing of drugs specified in Schedule X.

• All conditions mentioned to grant the license in Form 25 shall be applicable.

License to Manufacture Drugs Specified in Schedule X

Licenses to manufacture drugs included in Schedule X against the application in Form 24-F shall be granted in Form 25-F.

The applicant shall follow all conditions mentioned in conditions for the license granted in Form 25. In addition, the licensee in form 25-F shall follow conditions

• 1. The licensee shall forward a statement of sale to manufacturers, wholesalers, retailers, hospitals, dispensaries, nursing homes, and Registered Medical Practitioners every three months to the licensing authority of the concerned state

• 2. The licensee shall maintain details of all transactions in the bounded register with page number. Each register shall be maintained for at least five years from the last date of entry or for one year after the expiry date of the drug, whichever is later.

• 3. The licensee shall maintain the following information on Schedule X drugs in said register.

  • a. Date of issue.

  • b. Name of the drug.

  • c. Opening balance of stock on the production day.

  • d. Quantity received, if any, and source from where received.

  • e. Quantity used in manufacture.

  • f. Balance quantity on hand at the end of the production day.

  • g. Signature of the person in charge.

• 4. Accounts of production

  • a. Date of manufacture.

  • b. Name of the drug.

  • c. Batch Number.

  • d. Quantity of raw material used in manufacture.

  • e. Anticipated yield.

  • f. Actual yield.

  • g. Wastage

  • h. Quantity of the manufactured goods transferred.

• 5. Accounts of the manufactured drugs

  • a. Date of manufacture.

  • b. Name of the drug.

  • c. Batch Number.

  • d. Opening Balance.

  • e. Quantity manufactured.

  • f. Quantity sold.

  • g. Name of the purchaser and his address.

  • h. Balance quantity at the end of the day.

  • i. Signature of the officer in charge.

• 6. The licensee shall store Schedule X drugs in bulk form. If such drugs are required at a place other than the store then they shall be in the custody of a responsible person

• 7. The licensee shall comply with all requirements for “Good Laboratory Practices” as mentioned in Schedule L-I and “Good Manufacturing Practices” mentioned in Schedule M.

• 8. No schedule X drugs shall be supplied as physician samples.

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Loan licence

A loan license is issued to a person who does not have the facility to manufacture drugs. Loan licensees avail the facility of other licensed manufacturers that have manufacturing licenses in form 25. The loan licensee shall observe all conditions of a drug manufacturing license except having a manufacturing facility and laboratory to test and analyze drugs. A loan license is granted to manufacture drugs other than those specified in Schedule X of the Drugs and Cosmetics Act.

• Application for loan license and renewal of loan license for drugs other than those specified in Schedule C and C1 and Schedule X is submitted in form 24-A. A loan license shall be issued in form 25-A.

• Application for loan license for drugs specified in schedule C and C1 other than those specified in schedule X shall be submitted in form 27-A. A loan license shall be issued in form 28-A

• Application shall be submitted with licence fee of Rs 600/- (Rs six hundred) and inspection fee of Rs 1500/- (Rs one thousand and five hundred only). One application should not be more than 10 drugs from one category. If an application for a loan license shall have more than ten items of drugs from one category then the applicant shall deposit an additional fee of Rs300/- for each drug. The applicant shall also submit consent of the licensee whose facility shall be utilized by the loan licensee.

• Application for renewal shall be submitted before the expiry of loan license along with license fee (renewal fee) and inspection fee as stated above. The loan licensee can also submit an application for renewal after the expiry of the loan license but within six months from the date of the expiry of the loan license. Here fee shall include the licence fee, and inspection fee with a late fine fee that is Rs 1000/- per month.

• A loan license is issued in form 25-A. A certificate for renewal of loan license is issued in form 26-A. The loan license or renewal certificate of loan license remains valid for five years from the date of issue. A loan license and certificate of renewal can be canceled or suspended before the completion of five years.

• If the licence in Form 25 of the facility provider is cancelled or suspended then automatically loan licence shall also considered as suspended.

• The loan licensee shall test each batch of raw materials and finished goods. Records of tests and analysis shall be maintained for 5 years from the date of manufacture. If a drug has an expiry date then the record shall be maintained at least for two years from the date of expiry.

Repacking Licence.

• A license is issued to repack drugs other than those specified in Schedule C and C1. Application to repack drugs is submitted in form 24-B and repacking licence is issued in form 25-B.

• The applicant shall follow the following conditions for the grant of a repacking license or for renewal of the repacking license

• 1. Repacking of drugs shall be carried out under hygienic conditions

• 2. Repacking operation shall be carried out under supervision of competent staff.

• 3. Competent staff available should be approved by the licensing authority. Qualification of Competent staff for repacking purposes shall have

• a. degree or diploma in pharmacy or

• b. be a registered pharmacist under the Pharmacy Act 1948 or

• c. Passed intermediate examination (10+2) with chemistry as the main subject or any examination equivalent to it or any examination recognized by licensing authority equivalent to it or

• d. Passed matriculation examination with not less than 4 years of experience in manufacturing, dispensing, or repacking drugs

• 4. Premises licensed for repacking drugs shall comply with all provisions mentioned in schedule-M.

• 5. The testing unit shall be separate from the repacking unit on the premises.

• 6. Tests and analysis require sophisticated instruments that can be carried out in any approved laboratory for this purpose by the licensing authority.

• 7. The licensee shall have sufficient space and arrangements to store drugs and repack drugs.

• 8. The licensee shall maintain a detailed record of repacked drugs.

• 9. Licence shall be kept in licensed premises.

• 10. Any change in competent staff shall be informed to the licensing authority and accordingly it shall be entered into the license.

• 11. Repacked drug labels shall have all information present on bulk drug packing. In addition repacking licence number shall also be mentioned on the label.

• 12. The licensee shall allow an authorized drug inspector to inspect the premises facility for repacking and analysis, records maintained, storage facility, qualification of competent staff, etc. He can take samples of drugs.

• 13. The repacking license and renewal certificate shall remain valid for 5 years from the date of its issue. It can be canceled or suspended by the licensing authority before the completion of five years if the licensee does not comply with provisions of the Drugs and Cosmetics Act and rules.

• 14. The licensee shall maintain an inspection book in form 35.

• 15. The licensee shall maintain a reference sample from each batch. The amount of sample should be two times more than required for testing and analysis. If a drug has an expiry date then a reference sample shall be maintained for at least three months from the date of its expiry.

Alok Bains

License to Manufacture for Examination, Test, or Analysis

• A license is required to manufacture drugs in small quantities for examination, testing, or analysis. If the composition of the drug is not recognized as safe by experts then a license shall not be granted by the licensing authority. A person applies in Form 30 for a license to manufacture for examination, test, or analysis. The application shall be countersigned by the head of the institution or director of the firm or company. The application shall be submitted with the prescribed fee. A license issued in Form 29 shall remain valid for one year from the date of issue of the license. The license can be renewed. The renewal certificate remains valid for one year from the date of renewal. License can be canceled or suspended before the completion of one year if the licensing authority observes that conditions of the Drugs and Cosmetics Act and rules have not been followed. The licensee can appeal to the state government against the decision of the licensing authority within three months from the date of cancellation.

The licensee in form 29 shall comply following conditions

• 1. The licensee shall use the drug only for examination, test, or analysis.

• 2. The licensee shall allow an authorized drug inspector to inspect premises and other facilities.

• 3. The licensee shall maintain a register to maintain a record regarding the quantity of drug manufactured, quantity of drug used in examination, test, or analysis, and detail of the person to whom the drug was supplied.

• 4. The licensee shall comply with all instructions issued by the licensing authority under the Drugs and Cosmetics Act and rules.

• 5. The licensee shall maintain an inspection book.

• 6. The label on the container of the manufactured drug should bear the accepted scientific name of the drug, the name and address of the manufacturer, and the purpose of the product.

• 7. Examination, test, or analysis should be carried out under the supervision of qualified staff.

• 8. Report of examination, test, or analysis shall be furnished in the prescribed form.

• 9. Records of test, analysis, and examination shall be maintained at least for two years for drugs having expiry dates. It shall be maintained at least for 6 years for drugs having no stated expiry date.

• 10. An adequate facility shall be provided for the storage of drugs.

• 11. Reference Books, Reference literature shall be provided to carry out examination, test or analysis.

Alok Bains