Child-friendly HIV drug gets govt. nod
CDSCO has registered the oral pellet form for easy use
•The Central Drugs Standard Control Organisation (CDSCO) has registered the child-friendly HIV drug in oral pellet form, ending months of uncertainty for the HIV community. This has opened up crucial supplies from Cipla Pharmaceuticals, a market leader in the HIV segment, to the National AIDS Control Programme (NACO), which had been struggling to source quality assured paediatric formulations of the drug.
•India ran out of Lopinavir syrup, a child-friendly HIV drug, in March after Cipla — the sole manufacturer of the drug — stopped production consequent to non-payment by the Health Ministry. The drug’s adult version has to be swallowed whole and thus cannot be administered to infants and young children.
•In March, over 600 children had written a letter to Prime Minister Narendra Modi, asking for a quick resolution to the matter.
•On May 25, an expert committee of the CDSCO had permitted the child-friendly and heat-stable pellet formulation of the HIV drug lopinavir/ritonavir (LPV/r) to be registered.
•The pellets, which come in capsules and are dosed by weight, can be sprinkled (but not stirred or crushed) over a small amount of soft food. For infants — who must be able to swallow them — the pellets can be added to a spoonful of breast milk or put on the infant’s tongue.
•“The lack of child-friendly HIV formulations is one of the major reasons why there is such a large treatment gap between adults and children, and is also why we consider paediatric HIV to be a ‘neglected disease’,” said Dr. Suman Rijal, Head, Drugs for Neglected Diseases (DNDi) India.
•“The registration of the pellets is a positive sign as the needs of children are being addressed. Children are some of the most vulnerable HIV patients, and we cannot forget their special R&D needs,” Dr. Rijal added.
Navy eyes advanced subs
Not keen on ordering more Scorpenes, which have already been delayed
•With the Strategic Partnership model for procurement of defence platforms now official, the Navy is not interested in ordering additional Scorpene submarines, a senior naval source told The Hindu. Six Scorpenes are now under construction, and the Navy is keen to accelerate the tender for a new line of advanced submarines under Project-75I. “It is logical that we want to go in for new submarines under Project 75I as they are more advanced,” one officer said.
•Another officer observed that the Scorpene programme was already delayed and the technology would be so much older. “Why get more of them when the more advanced ones are already in the pipeline,” he said.
•Mazagon Docks Ltd., Mumbai, is manufacturing the Scorpene conventional submarines with technology transfer from DCNS of France under a $3.75-billion deal signed in October 2005. The first submarine Kalvari is set to join the Navy in August and all six are expected to be inducted by 2022.
•India and France have held informal discussions for three additional Scorpenes as a follow-on contract.
•With the SP policy delayed, the discussions were expected to gain momentum during the strategic dialogue at the end of the year. However, there is a change of thought with the government notifying the SP model as a chapter of the Defence Procurement Procedure.
Project-75I
•The P-75I submarines will be more modern and advanced with all of them equipped with Air Independent Propulsion modules to enhance the reach and stealth characteristics. AIP modules were not part of the Scorpene deal, and the Navy is trying to have them fitted on the last two Scorpenes. That is contingent on the timely delivery of the AIP being indigenously developed by the Defence Research and Development Organisation. The deal for six submarines under P-75I is expected to cost about ₹50,000 crore and the tender process will begin soon as per the guidelines of the SP model.
IMD predicts more rain this monsoon
Update says rainfall will be ‘normal’; private forecaster Skymet sticks to ‘below normal’ forecast.
•The country is likely to get more rain than was originally forecast in April, the India Meteorological Department (IMD) has said. Rainfall would be ‘normal’ and around 98% of the Long Period Average (LPA), the IMD said in an update on Tuesday. This is 2% more than the 96% or ‘near normal’ rain it had forecast in April.
•In the update, the IMD also said rains in July and August, the most important monsoon months for the kharif crops, would be 96% and 99% respectively, of what was normal.
•Spatially too, the IMD expects a balanced geographical distribution. The season rainfall is likely to be 96% of the historical average in north-west India, 100% of the LPA over central India, 99% of the LPA over the south peninsula, and 96% of the LPA over north-east India, with a model error of ± 8 %. (The LPA is a 50-year average of the monsoon rains in India.)
El Nino is weaker than anticipated, says IMD
•The IMD’s optimism about more rainfall is largely premised on hopes that a strong El Nino, which, as per its earlier forecast, was expected to surface in the later half of the monsoon, would now be much weaker than anticipated. “A weakened El Nino is largely why we expect better rains,” said Madhavan Rajeevan, Secretary, Earth Sciences Ministry.
•In April, the IMD had said there was a 38% chance of near normal rains (96% of the LPA). Now the models showed a 50% chance.
•The El Nino — characterised by surface waters of the equatorial Pacific warming up by more than half a degree — is known to dry up monsoon rain every six out of 10 years. A positive Indian Ocean Dipole (IOD) is said to buffer the impact of El Nino and contribute to better rains. (The IOD is a swing in surface temperatures that turns the western Indian Ocean alternately warmer and then colder than the eastern part of the ocean.)
New model
•In April, the IMD shifted to using a new monsoon forecast system, called a dynamical model that works by supercomputers simulating the weather and extrapolating it.
•It plans to make this as the base for all future forecasts, ranging from short-term weekly forecasts to the trajectory of the four-month- long monsoon. However, for its June update, the IMD chose to rely on its workhorse statistical model that forecasts the monsoon based on six meteorological parameters.
•The dynamical model, according to the IMD statement, showed monsoon rains to be 89 cm or 100% of the LPA. “In April, both models showed the same. It’s good for computing the all-India figure but not yet good at capturing the regional spread,” said Mr. Rajeevan. “In the next few years, we hope to move entirely into the dynamical mode.”
•Private weather forecaster Skymet said it was sticking to its “below normal” forecast at 95% (with an error margin of +/-5%) of the LPA. Rainfall for July stood at 94%, while for August it was 93% of the historical average.
As July 1 nears, GST interface not ready
Third party GST Suvidha Providers say only piecemeal implementation possible by deadline
•While the government remains committed to rolling out the GST regime from July 1, GST Suvidha Providers (GSPs), who are expected to help taxpayers cope with the transition to the new regime and its compliance paperwork, may only be operationally ready a few months down the line, say industry players.
•“Being very upfront, we are not too confident about the July 1 roll-out deadline,” Tejas Goenka, executive director at Tally Solutions, one of the 34 GSPs so far approved by the GSTN, told The Hindu .
•“The GSP model is not the only solution for the GSTN to meet its obligation to the citizens of the country — which is to get a system ready on which they can file their returns. It need not be that the GSP model will be out by July 1.”
Convenient methods
•Under the GST regime, the GSPs are expected to provide convenient methods to taxpayers to access and upload their documents and returns onto the GST Network (GSTN), the information technology backbone of the new indirect tax regime.
•“Sitting on June 6, we aren’t confident that the GSP business will be ready,” Mr. Goenka added. “What will likely happen is that in the first two months, the government will say: ‘Let us get the basics right and start with pushing the new system out. On July 10, July 15, July 17 and July 20, (the dates on which the monthly I-T returns are to be filed by companies) let people file using the government portal, the offline solution.’ They’ll do something like that to get people to comply and then they will start pushing the GSP/ASP model over time.”
SC reserves order on postgraduate quota for in-house students
Aligarh Muslim University, Banaras Hindu University had opposed Allahabad HC order setting aside 50% reservation
•The Supreme Court on Tuesday reserved its order on a Allahabad High Court decision setting aside 50% reservation for in-house students for admissions to postgraduate courses in Banaras Hindu University (BHU) and Aligarh Muslim University (AMU).
•A Vacation Bench of Justices Ashok Bhushan and Deepak Gupta heard submissions made by Additional Solicitor General Maninder Singh, for BHU, to stay the May 29 High Court order.
•Mr. Singh submitted that the prevalent PG admission policy cannot be reversed by opening up the 50% reserved seats for candidates selected through NEET.
•He submitted that the High Court passed the orders without even considering the point that the admission regulations of the Medical Council of India of March 10 were not under challenge.
Supreme Court decision
•Mr. Singh argued that the High Court changed the reservation policy of two central universities merely on the basis of a writ petition.
•Referring to the Supreme Court’s own decision in the 2003 Saurabh Chaudhary case setting down guidelines for PG admissions, the law officer contended that only 50% are to be filled by the all India quota.
•Citing AIIMS and PGI, Chandigarh as examples, Mr. Singh said institutional preferences play an important part in admissions.
Admissions on
•Senior advocate Salman Khurshid, for AMU, submitted that admissions to 149 of 195 seats were already complete. The Supreme Court said it would pass orders on Wednesday.
Airfares from Doha likely to rise
More Indians expected to return home as situation is ‘volatile,’ says an analyst
•The decision by Saudi Arabia, the UAE, Egypt and Bahrain to isolate Qatar on charges of harbouring terrorists and to impose flying restrictions on the country, will lead to a sharp rise in airfares to India from Doha as more Indians are expected to head back home, said analysts.
•“We expect more people to take the next available flight to come back home and not many people would like to go there at this point of time considering the volatile situation,” an analyst said. There are about 6.5 lakh Indians or people of Indian origin staying and working in Qatar, who are now expected to relocate.
•“Loads in onward flights will be less while incoming flights will have more pressure,” an airline executive said.
•As Emirates, Etihad Airways, fly Dubai, Air Arabia decided to suspend all flights operations to Doha from Tuesday onward, there would be more pressure on Indian carriers flying into Doha, analysts said.
Flights suspended
•Qatar Airways on Tuesday suspended all flights to the Kingdom of Saudi Arabia, the UAE, the Kingdom of Bahrain and Egypt until further notice. “All customers booked on affected flights will be provided with alternative options, including the option of a full refund on any unused tickets and free rebooking to the nearest alternative Qatar Airways network destination,” the airline said in a statement.
•Though its operations to India and elsewhere are expected to be normal, any further sanctions could jeopardise its prospects.
•“Indian carriers will benefit at any loss to Qatar Airways,” another airline official said adding Qatar Airway’s rivals in West Asia will eye its passengers flying onward.
•“The major casualty will be Qatar Airways which transports a large chunk of its passengers from India to onward destinations in the U.S. and Europe. Now fliers will be cautious to fly in that carrier due to the ongoing uncertainties,” said an analyst asking not to be named as he has business dealings with Qatar Airways.
Emirates preferred
•More than 80% of the airline’s passengers originating from India fly through Doha to onward destinations. Out of all passengers from India taking a West Asian carrier, approximately 20% fly by Qatar Airways. A majority prefer Emirates followed by Etihad Airways through their hubs in Dubai and Abu Dhabi respectively. Bahrain’s flag carrier Gulf Air is also expected to benefit.
•So far, Indian carriers have been operating regular services to Doha. These include Air India Express, Jet Airways and IndiGo.
•Indigo, in a statement, said, “We are closely monitoring the situation. There are no changes in the current flight schedule. All necessary steps will be taken in the best interest of our passengers.” Jet Airways officials said their flights are operating as per schedule.
•A pilot who operated a flight from Doha on Tuesday morning said that he noticed uneasiness among the citizens of Qatar as well as those working there.
•“Everyone I spoke to was shocked. No one knows what is going to happen next. The decision to impose the sanction on Qatar came as a surprise,” he said, asking not to be named.
•“We flew over the normal route. There were no airspace restrictions. But one never knows what is in store,” he said.
•In case the situation escalates further and Qatar Airways comes under pressure, it is feared that thousands of cabin crew and hundreds of pilots from India working in that airline would be adversely impacted.
•The uncertainty on Qatar’s economy and the finances of its flag carrier also has raised a question mark on Qatar Airways’ plans to start an airline in India.
The art of the free trade agreement
A European Court of Justice ruling will have bearing on India-EU pacts.
•During their recent meeting in Germany, Prime Minister Narendra Modi and German Chancellor Angela Merkel agreed on the need to resume India-European Union (EU) free trade agreement (FTA) talks. These negotiations, covering trade, investment protection and intellectual property, have remained deadlocked since 2013.
•The recent and hasty unilateral termination of bilateral investment treaties (BITs) by India with many EU member countries including Germany has complicated things further, leaving many European businesses worried about investment protection in India. As India prepares to resume FTA negotiations on all issues including investment protection, a recent landmark decision by the European Court of Justice (ECJ) — the highest court in the EU in matters of EU law — which has not attracted much attention assumes importance.
The ISDS mechanism
•The European Commission negotiated an FTA with Singapore from 2010 to 2013 covering a wide range of issues such as tariff reductions, intellectual property and investment protection including the investor-state dispute settlement (ISDS) mechanism. The ISDS provision in the EU-Singapore FTA gives investors a choice between bringing a dispute against a host state before the national court of the country where the investment has been made and submitting the dispute to international arbitration. The European Commission and the EU member states disagreed as to who had the competence to ratify the FTA. The ECJ decided that EU had the exclusive competence over almost all aspects of the FTA barring non-direct foreign investment — also known as portfolio investment — and the ISDS mechanism. In other words, for agreements containing non-direct foreign investment and/or ISDS provisions, EU member states enjoy mixed competence to approve such treaties. The court held that since the ISDS provision allowed the removal of the disputes from the jurisdiction of the courts of an EU member state, it could not be done without the consent of the member states.
•This decision will impact the EU’s ongoing FTA negotiations, including with India. As Anthea Roberts of the Australian National University has argued, to honour the ruling, the EU might consider different options. First, it could decide to jettison the ISDS clauses in all its future FTAs. In other words, it may negotiate FTAs where disputes between investors and states would be resolved using the state-state dispute settlement (SSDS) mechanism. Given India’s protectionist stand on BITs and ISDS, as reflected in the 2016 Model BIT, India might be happy with this outcome. However, it is unlikely that the EU would totally abandon the ISDS system. Its FTA-text with Singapore and also the recently signed EU-Canada FTA reveals the EU’s preference for ISDS. Though, one major change is that the EU, in its FTA with Canada, has moved away from arbitration to a bilateral investment court system to settle investor-state disputes. Under this system, both countries nominate a roster of 15 tribunal members for a five-year period, and three members shall be randomly selected to serve on one tribunal. In addition to this, an appellate tribunal will be established to review tribunal decisions. Not just this, the EU is also keen to set up a multilateral investment court (MIC) with an appellate mechanism as reflected in Article 8.29 of the EU-Canada FTA.
•Second, the EU could negotiate an FTA with ISDS provisions subject to the treaty being approved by all EU member states. However, this option is not feasible because all EU member countries might not ratify such an FTA. Third, it could negotiate the main FTA without an ISDS provision but make ISDS provisions a subject matter of an optional protocol provided this is permitted under EU law. The optional protocol could theoretically bind the EU’s partner country and only those EU member countries that ratify it and thus give their consent to the removal of investor-state disputes from their jurisdiction.
Challenges for India
•Assuming the EU exercises the third option and tailors the ISDS optional protocol on the lines of the EU-Canada FTA, India will have to think about its ISDS negotiating strategy carefully on three fronts. First, will India accept allowing foreign investors to submit cases to international tribunals without first resorting to domestic courts? The 2016 Indian Model BIT requires a foreign investor to litigate in national courts for at least five years before approaching an international tribunal. Second, is India prepared to accept the proposal of setting up a MIC and submit to the jurisdiction of such a court? This would mean that all BIT disputes would be settled by the MIC and not through ad hoc arbitration as India currently proposes in its Model BIT. There is a lot of merit in developing an MIC because it will help fight the vices of current ISDS system based on ad hoc arbitration. The MIC system will bring in tenured-judges with expertise in international investment law (IIL) unlike the party-appointed arbitrators, many of whom are not experts in IIL; usher in transparency in the ISDS system; introduce an appellate mechanism to correct errors of law made by tribunals of first instance, which is missing in the current ISDS system. Third, pending the creation of the MIC, will India accept the creation of a bilateral investment court system with tribunal members being appointed for a five-year period and with an appellate mechanism? The method of dispute resolution in the Indian Model BIT is based on ad hoc arbitration through party-appointed arbitrators though the possibility of creating an appellate mechanism is recognised.
•India should use the ECJ decision to rethink the best way of approaching the ISDS, such as whether it should move forward with the option of negotiating for a MIC. As a democracy based on the rule of law, India should actively engage with the EU as part of its FTA negotiations, towards creating a robust and transparent international judicial system like the MIC that would protect foreign investment from state’s regulatory abuse.
