|
Health ministry issues draft notification to amend D&C Rules to bring in several changes
|
|
Gireesh Babu, New Delhi
May 31 , 2025
|
|
|
The Union health ministry has issued draft notification to amend the Drugs and Cosmetics Rules, 1945 to bring in several changes including inclusion of bacterial endotoxins in the testing requirements, provisions to ensure antimicrobials are not used in food products, and exclusion of chemical contraceptives such as centchroman and ethinyloestradiol from Schedule H of the rules, among others.
These changes are in tune with the recommendations of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) after detailed deliberations in their meetings in the past.
The Ministry said that the draft notification has been issued after consultation with the DTAB and it will be taken into consideration on or after the expiry of a period of 30 days from the date of publication of the draft in the Official Gazette.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central government," it added.
The draft suggests substitution of the Rule 121A of the Drugs Rules, which is currently mandating tests for pyrogens for parenteral large volumes of 10 ml or above at a time.
This provisions would be replaced with a provision for test for bacterial endotoxins-pyrogens, which stipulates "Solution of substances intended for parenteral administration (as well as water or any other aqueous solvent supplied along with such substances) shall comply with a test for bacterial endotoxins or where justified and authorized, with the test for pyrogens. The test for Bacterial endotoxins-pyrogens shall be carried out as per current edition of Indian Pharmacopoeia (IP).”
The DTAB, in its 84th meeting in 2019, observed that the existing condition is applicable for products with 10ml volume or more, while there is no such provision mentioned in the Drugs and Cosmetic Act and Rules 1945 for pyrogen testing, for the products with less than 10ml.
This makes it difficult to apply tests for pyrogens as per Rule 121A in products with less than 10ml volume, while as per I.P 2018, a test for pyrogens is designated for products irrespective of their volume. The DTAB suggested amendment to the provision to bring alignment in IP and the Rules.
Amendments in Form 20B and 20G, related to wholesale of drugs under certain schedules, to restrict the qualification of the competent person eligible for holding the license for wholesale of drugs.
Conditions that the sale shall be made under personal supervision of a competent person, along with the person's name will be included into these two forms, once the notification is finalised. The conditions of license would also be amended to mandate that the licensee shall report to the licensing authority any change in competent person within one month of such change.
Another amendment has been proposed to bring in changes to the Drugs Rules to the effect that no antimicrobials should be sold by the traders to the non-pharmaceutical industries who are not holding requisite license.
The draft proposes to delete the exemption provided to wholesalers under the Form 20B and 20BB to sell the drugs under certain schedules, to manufacturers of beverages, confectionery biscuits and other non-medicinal products, where such drugs are required for process of these products, without requisite license sell stock of distribute the drug.
Instead, it proposes to add a provision that "Provided further that the conditions shall also not apply to the sale of any drug except antimicrobial drugs to a manufacturer of beverages, confectionery biscuits and other non-medicinal products, where such drugs are required for processing these products".
In the Form 21-B and Form 21BB, the exemptions provided to sell the drugs to a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non-medicinal products, where such drugs are required for processing these products will be cancelled.
Instead a fresh proviso, "Provided further that the conditions shall also not apply to the sale of any drug except antimicrobial drugs to a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non medicinal products, where such drugs are required for processing these product," shall be added.
Another amendment proposed in the draft is for exemption of chemical contraceptives mentioned in Serial No 15 of Schedule K from the provisions of Schedule H. The proposal is to add a fifth foot note to Schedule H, that "Class of drugs mentioned at serial no.15 of Schedule K shall not be covered under this Schedule."
The serial no.15 of Schedule K lists chemical contraceptives having compositions such as DL-0norgestrel 0.30 mg and ethinyoestradiol 0.30 mg, levonorgestrel 0.15 mg and ethinyloestradiol 0.03 mg, centchroman 30 mg, desogestrel 0.150 mg and ethinyloestradiol 0.030 mg, and levonorgestrel 0.1mg and ethinyloestradiol 0.02 mg.
However, the drugs centchrom and ethinyloestradiol are also listed under the Schedule H as entry number 101 and 186, respectively, which has resulted in confusion among the manufacturers and various regulators.
The 91st DTAB meeting held on August 14, 2024, noticed that the finished formulation of these drugs centchroman and ethinyloestradiol attracts the labelling requirement of clause (b) of sub-rule (1) of rule 97 of Drugs Rules. Accordingly, the label should bear the caution "Not to be sold by retail without the prescription of a Registered Medical Practitioner.”
However, the drugs levonorgestrel-0.15 mg + ethinyloestradiol-0.03 mg and Centchroman30 mg are exempted with regard to provision of sale licence under entry no. 15 of Schedule K, which makes the requirement of prescription by RMP contradictory, it observed.
"Accordingly, it was proposed to make the certain amendments under Drugs Rules, 1945 to avoid contradiction in labelling of products namely Levonorgestrel-0.15 mg + Ethinyloestradiol-0.03 mg and Centchroman-30 mg. DTAB deliberated the matter and agreed for the dose specific amendment in Schedule H under Drugs Rules, 1945," it added.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|