IPC includes dissolution test in IP: Read details

IPC had discussions with the stakeholders on the proposal to include dissolution tests in prolonged release formulations in the IP.

1537
Indian Pharmacopoeia Commission IPC
IPC

Last Updated on December 26, 2023 by The Health Master

The Indian Pharmacopoeia Commission (IPC) has included dissolution tests in prolonged release formulations in the Indian Pharmacopoeia (IP) to address the issue of different dissolution profiles of different brands currently being marketed in India.

Dissolution profiles of prolonged-release formulations vary from manufacturer to manufacturer and may significantly affect the pharmacokinetic efficacy and safety of the product.

A flexible monograph approach will be adopted in the IP, with multiple dissolution specifications in one monograph, to assess the quality of all approved products. 

Accordingly, the labeling requirements of such products would specify the dissolution method number on the label of the product for effective implementation of the flexible monographs.

IPC had discussions with the stakeholders on the proposal to include dissolution tests in prolonged release formulations in the IP.

It has been agreed that IPC would start including the dissolution tests in prolonged release monographs which are under development.

Simultaneously, IPC will revise official monographs in order to include dissolution specifications based on three point criteria:

The dissolution profile of the first product approved by the Drugs Controller General of India (DCGI), the dissolution profile recommended by OGD / USP, and the dissolution profile proposed by the stakeholders (to be accompanied with clinical data or IVIVC data of their equivalence with the first product approved by the DCGI).

If there is a proposal from stakeholders to include a different dissolution profile in the IP monograph, bioequivalence data with the international reference product or the first product approved by the CDSCO will be required before including alternative dissolution specifications in the IP.

“Monographs on the widely used drugs, such as metformin, sodium valproate, domeperidone, and rabeprazole, have to be prioritized for setting dissolution specifications in the IP,” according to an IPC official.

Latest Circulars: (IPC) Indian Pharmacopoeia Commission

Latest Notifications regarding Pharmaceuticals

Latest on National Formulary of India (NFI)

Safety alerts issued by IPC

Online purchase: procedure

Books: IP and NFI
Rates-and-Procedure-to-purchase-of-different-volumes-of-IP-and-NFI

Click here to purchase Books: IP & NFI

IP Reference Substances
Click here to purchase IP Reference Substances

Impurity Standards
Click here to purchase Impurity Standards

Monographs

Pharmaceuticals Monograph
Click here for Pharmaceuticals Monograph

Veterinary Monograph
Click here for Veterinary Monograph

NPPA fixes retail price of 12 formulations: January 2023

Drug recall: Epinephrine API recalled due to this reason

Deadline for Medical Colleges to submit PG Admissions info: NMC

NPPA revised Retail Price of 93 scheduled formulations: January 2023

Tramadol: 3 Pharmaceutical Companies under scanner

NABL suspends accreditation of 80 laboratories

NPPA fixes Retail Price of 4 scheduled formulations: January 2023

List of approved FDCs (Fixed Dose Combinations) Updated

List of approved New Drugs Updated

Latest Notifications regarding Pharmaceutical

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news