Pharma sector Current Affairs

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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Two Experimental Ebola vaccines found safe, effective in human trial

The clinical trials of two experimental Ebola vaccines cAd3-EBOZ and rVSV-ZEBOV were found to be safe and capable of eliciting immune response against Ebola virus that lasts for at least one year.

The findings were based on a study of clinical trials on 1,500 adults that began during West Africa Ebola outbreak. Three groups of 500 volunteers received one of the vaccine candidates or a placebo (saline injection).

Key Facts

During clinical trials, it was observed that responses to both vaccine candidates were modest at one week. However, by one month, 71% of cAd3-EBOZ recipients and 84% of rVSV-ZEBOV recipients developed an antibody response compared to 3% of placebo recipients.

These trials have yielded valuable information for development of these two Ebola vaccine candidates and also demonstrated that well-designed, ethically sound clinical research can be conducted during an epidemic. These safe and effective Ebola vaccines will play important role in controlling inevitable future Ebola outbreaks in addition to existing classical public health measures.

Ebola virus disease (EVD)

EVD is viral hemorrhagic fever of humans and other primates caused by ebola viruses. It was first identified in 1976 in the Democratic Republic of Congo (DRC) in a village near the Ebola River, from which it takes its name. The virus is transmitted to people from wild animals and spreads in human population through human-to-human transmission. Fruit bats are natural host of this virus. It spreads through contact with body fluids of inflected persons such as blood, urine and saliva.

It also spreads through sexual transmission. Symptoms of EVD are high fever, bleeding and central nervous system damage. The average EVD case fatality rate is around 50%. However, in past outbreaks case fatality rates have varied from 25% to 90%. In 2014, Ebola virus had erupted periodically mainly across west and east Africa mainly in Guinea, Liberia and Sierra Leone. It was the deadliest outbreak of the virus in the history which had killed 11,000 people.

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