The manufacturing unit shall provide all facilities, adequate space, plant and equipment etc to manufacture drugs specified in the application submitted and specified in Schedule M.
The manufacturing unit shall provide premises that comply with all conditions prescribed in Schedule M of drugs and cosmetics rules.
Licensee shall comply with Good Manufacturing Practices (GMP) specified in Schedule M.
The applicant shall provide adequate staff, premises, and laboratory equipment to carry out tests of strength, quality and purity of substance at the testing unit. The testing unit shall be separate from the manufacturing unit. Both units shall have independent heads.
Tests require sophisticated instrumentation techniques or biological methods or microbiological methods other than sterility can be carried out in a laboratory approved by licensing authority for these purposes,
The head of the testing unit shall have a degree in pharmacy or pharmaceutical science or medicine or science from a recognised university. They shall have experience in testing drugs. Adequate duration of experience in testing and analysis of drugs shall be fixed by licensing authority that may vary from state to state.
Manufacturing of drugs shall be carried out under the direct personal supervision of competent technical staff. At least one technical staff in the manufacturing unit shall be a whole-time employee.
Qualification of competent technical staff shall be
a). Graduate in pharmacy or pharmaceutical chemistry from a recognised university with eighteen months of practical experience in manufacturing drugs after completion of his graduation. However, a person can undergo practical training for 6 months during his/her graduation. This six months duration of training shall be reduced from 18 months of training after completion of graduation.
b.) Graduate in science with chemistry as the principal subject from a recognised university. He/she has practical training experience of not less than three years in the manufacturing of drugs after completion of graduation.
c). Graduate in chemical engineering or chemical technology or medicine from a recognised university. He/she has practical training experience of not less than three years in the manufacturing of drugs after completion of graduation,
d). Holding any foreign qualification equivalent to any one of the above-said qualifications and permitted by the central government to work as a competent person under the drugs and cosmetics act.
e). Person directly involved in the manufacturing of drugs and his name has been entered in the licence before 29th June 1957 shall be considered as competent staff.
f). For drugs other than those specified in Schedule C and C1 and Schedule X to be manufactured for the veterinary purpose, the qualification of competent staff shall be a graduate in Veterinary Science or General Science or Medicine from a recognised 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 recognised university with at least eighteen months of practical training and experience to manufacture such drugs after completion of the degree program.
g. 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 licensing authority depending upon adequate experience to manufacture such substances
The applicant shall have adequate facility to store drugs manufactured in licensed premises,
Applicant applying to manufacture patent and proprietary medicine shall furnish the following data evidence to justify that patent and proprietary medicines,
a). contain ingredients in quantity to be used for therapeutic purposes,
b. Vehicles, additives, and pharmaceutical aids are for pharmaceutical purposes and safe for use,
c). Stable in recommended storage conditions.
d). Contain active ingredients with therapeutic justification
e). have approval in favour of the applicant to manufacture drug formulation under the category of a new drug.
Duration of licence: Rule 72 of the drugs and cosmetics rules states that license or renewal of a licence shall remain valid for five years from the date of manufacturing or the date of renewal. The licensing authority may cancel or suspend the licence before the completion of five years if the licensee did not comply with provisions of the drugs and cosmetics act and rules.
The renewal application shall be submitted before the expiry of the licence or within six months from the date of expiry. If applied for renewal after the expiry of the licence then the applicant shall also deposit an additional fee. After the application is submitted for renewal, the licence shall remain valid till further order from the licensing authority.
Renewal licence 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
Licensee shall maintain premises, equipment and staff as per requirements of the act,
Licensee shall comply with all provisions that will be further included in chapter IV of drugs and cosmetics rules.
Licensee shall test or analyse each batch of raw materials to be used in manufacturing and each batch of the final product. Testing and analysis shall be carried out in his/her own laboratory or in a laboratory approved by the government for this purpose.
Licensee shall maintain a record/register of testing and analysis showing all particulars specified in schedule U of the Drugs and Cosmetics Rules. The record shall be maintained for a period of 5 years from the date of manufacturing,
Licensee shall maintain record/register detail of manufacturing showing all particulars specified in schedule U of the Drugs and Cosmetics Rules. The record shall be maintained for a period of 5 years from the date of manufacturing,
Licensee shall allow the authorised drug inspector to inspect licensed premises about staff employed, equipment and facility available for manufacturing and analysis, registers and records maintained, etc. An authorised drug inspector can enter into premises with or without prior notice to investigate provisions of the drugs and cosmetics rules are followed or not.
Authorised drug inspectors can take samples of drugs manufactured on premises for testing and analysis.
Licensee shall maintain an inspection book in form 35. Drug inspector shall put his/her remarks in the register at the time of inspection.
Licensee shall furnish a sufficient quantity of samples to the licensing authority or any other authority as directed by the licensing authority.
The licensing authority may stop the marketing of drugs of any batch on valid grounds. In this case, the licensee shall not sell drugs belonging to that batch. If that drug has already in the market for sale then the licensee shall withdraw it from the market.
Licensee shall inform licensing authority if there is any change in competent technical staff to manufacture and analyse work.
Licensee shall inform licensing authority if there is any change in the premises and plant mentioned in the licence.
Licensee shall maintain a reference sample from each batch. The quantity of samples shall be twice the requirement to perform tests 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.
Compiled by Alok Bains
