Public health experts say the move is a setback for those working towards a safer, more transparent clinical trials regime. The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials. In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.
Meanwhile, the latest amendment to the D&C Act follows recommendations by the Professor Ranjit Roy Choudhury Committee, which had suggested that academic research should be approved by the Institutional Ethics Committees. “We want to create a system in which research and innovation are not caught in red tape. This is part of the government’s ease of regulation reforms. Many students test existing drugs and their study is delayed because of permissions required from the DCGI. Now, their institutions’ ethics committees are authorised to allow them, which should nurture an environment of research in the country,” said G.N. Singh, DCGI, Central Drugs Standard Control Organisation.
Chances of misuse are obviously higher if you give anyone a free hand, said C.M. Gulhati, Editor ofMonthly Index of Medical Specialities . “The only defence for this decision can be that this is academic, not commercial, research. These are academic exercises. They cannot experiment with new molecules. The element of risk is lower but ethics committees need to be independent. It will depend on the institutions how they use it, which leaves a huge loophole.”
Violation of rights
In 2013, the Supreme Court banned trials after a public interest litigation petition brought to light that trials conducted in various parts of the country had violated patient rights as informed consent was not taken, and the patients subjected to clinical trials included newborns, children, pregnant women and mentally challenged persons.
GS I: ART & CULTURE
Siddis synonymous with dance, music.
Their rhythmic dance moves, colourful attire and appearance are unmistakably African. Siddi, the African tribe, has called India their home from the past 200 years. There are only about 55,000 Siddis in India today who live in small, secluded settlements in Karnataka, Maharashtra, Gujarat and parts of Goa. Even though their food, clothes and language are completely adapted to the local cultures of whichever part of India they live in, traces of their African roots still echo in their dance and music traditions.
A small group of Siddi tribe from Karwar in Karnataka is here in the city to showcase their dance form at the ongoing National Tribal Dance Festival. “The rhythm of music and dance flows in our blood. Even if you ask a child to dance, he/she will be able to instantly break into the rhythm,” says team leader of the group Julian Pedru Fernandes in an accented Hindi.
With Marathi and Konkani as their lingua franca, the Siddi families in Karnataka are Roman Catholics, Hindus and Muslims - all united by their distinct music and culture. Their songs tell the story of the way they live and reflect their passion for hunting. “Dance is an integral part of our lives. We express happiness and sorrow through it. In fact, after a hard day’s work, you can often see one person in the village start the dance, only to be joined by the entire community within no time,” says Julian. Sometimes the dance carries on throughout the night! “In our weddings even if there is no food, our traditional dance and music will certainly be there,” she adds. Julian explains that her parents and ancestors used to sing 100 songs in a jiffy. “With the influence of television and exposure to cities, the present generation can hardly remember 30 traditional songs. Over the years, the strong dance moves have also given way to a bit mellowed version of the original,” she says.
While agriculture is their main source of livelihood, the youngsters of the tribe are slowly migrating to cities and work as labourers. Interestingly, their tribe in Karnataka has 35 per cent literacy rate.
“In our community, women study more and are much more responsible and active than men,” says Mary B. Garibache, one of the group members.
Unlike other tribes, the Siddis do not enforce restrictions on marrying outside their community.
With a strong community bonding, the Siddis believe in the culture of sharing the day’s catch equally among all families in the village.
This ancient practice is still being followed in most Siddi tribe settlements.
GS III: ECONOMY
‘Market access for India’s services key to BTIA’
Obtaining greater access to the market for services in the European Union (EU) is key for the progress of the Broadbased Trade and Investment Agreement (BTIA) between the EU and India, Commerce Minister Nirmala Sitharman told.
The two governments are hoping to make progress on the trade deal during the 13th EU India Summit in Brussels .
In a global economic climate of falling demand and competitive currency devaluations, the textile industry was among those that had approached the Commerce Ministry and expressed a view that a free trade agreement with the EU would be beneficial to it, Ms. Sitharaman said. However, she added that India would also take up the issue of market access for its services in the EU.
“On services, for instance, India cannot be sitting and watching on data security,” Ms. Sitharaman said. India has not been granted “data secure” status by the EU, and this has hampered the progress of negotiations around the liberalisation of trade in services in the BTIA talks. Being considered ‘data secure’ is crucial for a number of services especially in the IT and ITES sectors.
Similarly, for the textile sector, “if access is not available, the negotiations go through a difficult patch. We still negotiate hoping there will be some give and take,” Ms. Sitharaman said. In response to a question on what had stalled the negotiations, Ms. Sitharaman said, the contours of the discussions had recently been widened by the EU to involve investments, not just trade in goods and services, converting a free trade agreement into a broader scope trade and investment agreement.
Re-iterating that India was not happy with higher fees for temporary United States work visas (H-1B and L-1 caterogies) Ms. Sitharaman said, “We are very clear we are taking them [the U.S.] to the WTO.” India initiated a dispute with the U.S at the WTO on this issue on March 3. This is against an increasingly disputatious background between India and the U.S. in the WTO with the trade body recently ruling in favour of the US in a case involving domestic component requirements in India’s solar panel program. India is also considering filing a counter complaint with the WTO on similar practices in the U.S.
The government’s objections to visa regimes extend beyond the U.S. After Brussels, Ms. Sitharaman will go to London where she will discuss U.K. visa issues with Immigration Minister, Mr. James Brokenshire.
Ms. Sitharaman said U.K. visa rules discriminate against Indian technical professionals including because they have hiked visa fees and have numerical caps on visas. Earlier in March, the U.K. government announced a fee hike across most visa categories including Tier 2 visas, used to employ skilled foreign workers in the U.K.