Cipla’s new HIV drug approved for registration
On May 25, an expert committee of Central Drugs Control Standard Organisation permitted the Cipla’s registration of HIV drug in a pellet formulation used to treat children with HIV.
The drug regulator’s expert committee conceded that finding patients and suitable institutions for a feasibility study to test the drug would be difficult and that there are ethical issues in conducting such a study in pediatric populations. The committee recommended approval of the product with the condition that National Aids Control Organisation will conduct post-marketing surveillance in the first 100 patients and submit the data.
The lopinavir-ritonavir drug combination is the backbone treatment regimen for HIV positive children below three years of age. The drug combination in pellet form is known to be better than the syrup that was used earlier. The syrup contains 42% alcohol, has to be refrigerated and is often rejected by children because of its bitter taste. Cipla’s product in the pellet formulation has no taste, no alcohol and can be stored at room temperature.
The lopinavir-ritonavir pellets are packaged as micro-tablets inside a capsule that can be opened and mixed with a child’s food. “With more children actually swallowing the medicines, there will be more survivors,” said Paul Lhungdim of the Delhi Network of Positive People. “These innovations represent very important progress in the fight to end AIDS in children.”
The expert committee had rejected Cipla’s application twice earlier on the ground that clinical trials were not conducted.
Registering the drug would have allowed the National AIDS Control Organisation to buy and use the drug to address the problem of frequent stock outs of paediatric HIV medication in the country.
Cipla had conducted clinical trials in Uganda and Kenya and had already been supplying the drug pellets outside India. The company sought a waiver for clinical trials among the Indian paediatric population.
Tribal women still need govt nod for sterilisation
The Chhattisgarh government has amended its 1979 order that said that protected tribal women who are a primarily vulnerable tribal group can seek sterilisation with the permission of the sub-divisional magistrate, the Indian Express reported.
In 1979, the health department of undivided Madhya Pradesh had restricted the sterilisation of members of these Primarily Vulnerable Tribal Groups. The justification at the time was that these vulnerable tribal groups had low health indicators and were in a danger of dying out.
A Public Interest Litigation was filed by Baiga families, one of the seven protected tribes of Chhattisgarh, two public health activists related to Jan Swasthya Sahyog and Jan Swasthya Abhiyan in Chhattisgarh. The PIL contended that the order was passed when the state was following an aggressive target based population policy. The order, the petition said, violated right to life and liberty.
The activists who filed the petition said that the new order is not much different from the old 1979 order, which said that the block development officer can give permission to get the sterilisation procedure done.
“The fact that they still have to ask for permission shows that really nothing has changed,” Sulakshana Nandi of the Jan Swasthya Abhiyan told the Indian Express.
230 swine flu deaths in Maharashtra
Swine flu or H1N1 influenza continues to claim lives in Maharashtra with the death toll touching 230 in June. Between January and December last year, the state had reported 26 deaths.
Officials from the Maharashtra health department observed that the number of deaths have not risen with the pre-monsoon showers. Monsoons are favourable for the transmission of H1N1 infection and officials fear that the monsoons would lead to a further rise in cases and deaths.
“In the last fortnight, we have not seen a rise in cases or deaths,” said Dr Pradeep Awate, in-charge of swine-flu surveillance in Maharashtra. “This means that the virulence of the virus has definitely not increased.”
The current strain in circulation, according to Awate spreads easily in hot climate. Hence, Awate and his colleagues feel that the cases might drop once monsoon hits the state. So far, the state has recorded 1202 cases of swine flu.
Earlier Dr MS Chadha, the influenza group leader at the National Institute of Virology in Pune told Scroll.in that there is a change in the virus. But, she said that that the change “is inconsequential for the clinical severity and transmission of H1N1 virus in circulation in India”.