The Union health ministry has issued a draft amendment to various rules under the Drugs and Cosmetics Rules, 1945, to include requirement of the manufacturing and loan licenses for drugs, biopharmaceuticals, and those under the Indian Systems of Medicine, among others, mandating submission of information related to post approval changes (PACs) with the licensing authority.
Amendments have been proposed in Rule 74 related to conditions for manufacturing license in Form 25, for drugs other than those specified in Schedules C and C(1) and X, rule 74B related to conditions of loan licence in Form 25A for the same drugs, Rule 74A related to conditions for license in Form 25B to repack for sale or distribution of drugs other than those specified in Schedules C and C (1), rule 78 related to conditions of licence under Form 28, Form 28B or Form 28D for license and loan license for manufacturing of biological drugs, psychotropic drugs, and large volume parenterals among others.
Similarly, amendments have also been proposed in Rule 78A, regarding conditions of license in Form 28A or Form 28DA under certain schedules, and rule 122-P regarding conditions of licence to manufacture and store blood products for sale or distribution.
The draft amendment proposes that any change in manufacturing process or excipients, packaging, shelf life, specifications, testing, documentation etc., the manufacturer shall inform the licensing authority in writing for such changes.
Under Rule 74, 74B, 78, and 78A, it is further clarified that in case of any major quality change (level 1), the manufacturer shall obtain prior approval from the lensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.
In case of any moderate quality change (Level II), the manufacturer shall obtain prior approval from the licensing authority, where the change has a moderate potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.
In case of minor quality changes (Level III), the manufacturer shall implement the change without prior approval from the licensing authority (except for cases of change in shelf life of drug substance and drug product), where the change has a minimal potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product. The annual submission shall be made to licensing authority by 1st quarter of every calendar year, it added.
Rule 74A and 122P, it has proposed for an amendment to add a provision that in case of any major change, the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.
Besides, the Ministry has proposed to amend the condition of license in the Form 25, Form 25A, Form 25B, Form 25C, Form 25D, Form 25E, Form 25F, Form 28, Form 28A, Form 28B, Form 28C, Form 28D, Form 28DA and Form 28E, to insert certain conditions after the last condition in each Form, to indicate that in the event of any change in manufacturing process, or other details, the manufacturer shall inform the licensing authority in writing for such changes.
This is provided that in case of any major or moderate quality change, the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.
The Ministry, releasing the draft, also issued a notice that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government," it added.
It may be noted that the Drugs Consultative Committee (DCC) has in 2023, recommended that the rules and conditions related to licensing of drugs should be amended appropriately to make it mandatory that the manufacturers provide the details of the critical or major post-approval changes to the licensing authority, and this should be mandatory as part of the inspection checklist of the drug regulator.
The Ministry, earlier this year, has issued a draft notification with proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in similar lines, with specific norms related to reporting of post approval changes to the licensed new drugs, both imported and manufactured in the country, to ensure their quality, safety and efficacy throughout the product lifecycle. It was proposed by categorising the post approval changes of new drugs, both imported and manufactured in the country, based on the impact of the changes in the quality of the drug.
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