Pharma sector Current Affairs

Indian Pharmacopoeia Commission approves modern animal-free testing for drugs

Indian Pharmacopoeia Commission (IPC) has in its 2018 edition of Indian Pharmacopoeia approved modern, animal-free tests for drug manufacturers. It will spare animals from suffering due to drug experiments.

2018 Indian Pharmacopoeia

It provides guidelines on tests for drugs manufactured and marketed in India. It replaces pyrogen test carried out on rabbits and abnormal toxicity test carried out on guinea pigs and mice with tests that can be done in test tubes. These guidelines will come into effect from July 1, 2018.

The pyrogen test will be replaced by bacterial endotoxin test or monocyte activation test which can be carried out in test tubes. For abnormal toxicity test, Vaccine manufacturers can apply for waiver by getting compliance certificate from National Control Laboratory.

Background

People for the Ethical Treatment of Animals (PETA) India was pushing for doing away with cruel methods of testing on animals for the past several years. It had written to IPC in 2015 with several suggestions. These suggestions were discussed in a meeting of expert committee on vaccine standards that was held in 2016 and few of them have finally approved by IPC.

Pyrogen test is carried out to check impurity or substance that can cause adverse side-effects. For the test, drug is injected into rabbit and animal is closely observed for feverish symptoms. The abnormal toxicity test is carried out to check potential hazardous biological contamination in vaccine formulations. This batch test is done before product is approved for marketing. In this, mice or guinea pigs are injected with vaccine. The scientists observe if there is death of any animal.


Indian Pharmacopoeia Commission (IPC)

IPC is an autonomous institution of Ministry of Health and Family Welfare to set standards of drugs in country. Its basic function is to update regularly standards of drugs commonly required for treatment of diseases prevailing in the region. These set of standards are published under title Indian Pharmacopoeia (IP) similar to British Pharmacopoeia and United States Pharmacopeia. IPC publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in form of IP. It also promotes rational use of generic medicines by publishing National Formulary of India. IPC was established by executive orders in 1945 according to Indian Drugs and Cosmetics Act, 1940. It is headquartered in Ghaziabad, Uttar Pradesh.

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NPPA fixes retail price of 30 drug formulations

Drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed retail price for 30 drug formulations, including those used for treatment of diabetes, bacterial infections and high blood pressure. The prices were fixed/revised under Drugs (Prices Control) Order (DPCO), 2013.

National Pharmaceutical Pricing Authority (NPPA)

NPPA is independent body under Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. It was set up in 1997. Its mandate is to fix/revise controlled bulk drugs prices and formulations, enforce prices and availability of medicines under DPCO, 2013. It also monitors prices of decontrolled drugs in order to keep them at reasonable levels. The regulator implements and enforces the provisions of DPCO. It is also entrusted with task of recovering amounts overcharged by manufacturers for controlled drugs from consumers.

Essential medicines

Essential medicines are those that satisfy the priority health care needs of the country’s population. They are listed with reference to the levels of healthcare namely primary, secondary and tertiary. They are generally based on the country’s disease burden, priority health concerns, affordability concerns etc.

In India, National List of Essential Medicines (NLEM) formed in 2011 decides the essential medicines. The list is prepared by the Union Ministry of Health and Family Welfare. NPPA fixes ceiling price of essential medicines of Schedule I under DPCO 2013.

The calculation for essential drugs is based on simple average of all medicines in particular therapeutic segment with sales of more than 1%. In respect of medicines that are not under price control, manufacturers are allowed to increase the maximum retail price by 10% annually.

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