📰 Govt. grants divisional status to Ladakh
Similar status demanded for Pir Panjal, Chenab
•Jammu and Kashmir Governor Satya Pal Malik on Friday granted Ladakh a divisional status, thus creating three administrative units of Jammu, Kashmir and Ladakh in the State.
•“The J&K government has approved the creation of a separate administrative and revenue division for Ladakh. It will comprise Leh and Kargil districts, with headquarters at Leh,” said a government order.
•Earlier, Ladakh was a part of the Kashmir division. A section in Leh has been demanding Union Territory status and it was backed by the BJP.
Biggest division
•The move leaves the Kashmir valley geographically the smallest division at 15,948 sq. km, Jammu division at 26,293 sq. km and Ladakh, the biggest division, at 86,909 sq. km.
•Ladakh will now get its own Divisional Commissioner and Inspector General of Police. “During the winter months, the entire Ladakh region remains cut-off from the rest of the country for almost six months. The remoteness and inaccessibility of the area makes it eligible for establishing a separate division,” said the government order.
•Ladakh’s Kargil and Leh districts already have separate hill development councils for local administrative powers.
•The Governor’s decision has fuelled demands for similar status to Pir Panjal and Chenab Valley regions.
•“If the people of J&K repose faith in the National Conference in 2019, our government will grant divisional status to Chenab Valley and Pir Panjal regions,” said NC vice-president and former CM Omar Abdullah.
•PDP president and former CM Mehbooba Mufti said: “The process of decentralisation of administrative control is good, though Ladakh already has hill development councils. However, we are forced to question the intent behind it. Chenab Valley and Pir Panjal regions should not and cannot be ignored because of underdevelopment in these areas,” said Ms. Mufti.
A political change beckons which will not be easy but it is as certain as the overthrow of the Shah
•Friedrich Nietzsche prophesised with remarkable accuracy that the 20th century would be marked by great wars fought in the name of philosophical ideas. But what Nietzsche could not have anticipated was that towards the end of the 20th century there would be a revolution in the name of god, establishing a Shi’ite theocracy. The Iranian revolution of 1978-1979 (picture) was a momentous development in the modern history of Islam. And it had a huge impact on all movements across the globe, especially those that were using Islamic frames of reference for political activism.
•Some, like the French thinker Michel Foucault, enthusiastically declared the Iranian revolution as the spirit of a world without spirit. Foucault wrote: “One bears on Iran and its peculiar destiny. At the dawn of history, Persia invented the state and conferred its models on Islam. Its administrators staffed the caliphate. But from this same Islam, it derived a religion that gave to its people infinite resources to resist state power. In this will for an ‘Islamic government’, should one see a reconciliation, a contradiction, or the threshold of something new?” Following Foucault, we can say that from the very beginning, the Iranian Revolution remained a significant social and political transformation full of paradoxes and unpredictable twists.
Clerical rule
•The Iranian revolution was surprising not because it caused a monarch to collapse, but because of the way in which people organised themselves and participated in massive demonstrations. Like many other revolutions, it united several groups, classes and parties who, despite different ideologies, were all against the old regime.
•Also, in the Iranian revolution as in the French and later the Russian revolutions, the coalition did not last very long and the Iranian clerics ended up having a leading role. But, the interesting point is that most non-clerics who were in the opposition against the Shah of Iran underestimated the probability of clerical rule, despite the presence of the clergy in all major political events in Iran since the Constitutional Revolution of 1906. Moreover, for too many observers inside and outside Iran today, events leading up to the revolution in 1979 took a mystifying and seemingly irrational course. But, unfortunately, those who try to explain hastily and emotionally the causes of the Iranian revolution and the Shah’s collapse generally only tend to focus on one or another specific issue such as the alleged corruption of the regime, the undemocratic ways of its rule, the effect of repression, or the economic gap between the rich and the poor.
Social tensions
•If we consider the Iranian revolution not only as a political event but also as a psychological watershed, exactly as it was the case with the rise of Hitler to power in 1933 in Germany, we can understand why many Iranians believed back in 1978 that there was a messianic nature to Ayatollah Khomeini’s leadership. In truth, Khomeini’s success in the Iranian revolution had certainly nothing to do with divine providence, but given that the Iranian population believed for centuries in the divine right of kings, it should have come as little surprise that the people were receptive to such ideas rather than having an acute sense of political pragmatism. Khomeini’s leadership, followed by the establishment of the Islamic Republic in Iran, therefore, can be understood in patrimonial terms, assisted by periodic doses of charisma. The immediate consequence of this socio-religious attitude was to institutionalise Khomeini’s role as the leader of the revolution.
•But there is also a political side to the story: Khomeini was not only popular among common Iranians for his uncompromising attitude to the Shah and his anti-imperialist and populist rhetoric since 1963, but also because he and his followers were fully ready and organised for the establishment of an Islamic regime in Iran. As a result, defying all the myths of secular modernisation and shattering all the political ideologies of modernity, the Islamic Republic became the first theocratic state in the modern world to have institutionalised the Shi’ite idea of Velayat-e-Faqih, or the “rule of the jurist”. However, the institutionalisation of Khomeini’s role as the “faqih” did not manage the implicit tensions which continue to exist between tradition and modernity.
•Despite total Islamisation and the reign of terror unleashed on political groups, there were advancements of Iranian civil society due to demographic changes, the rise of literacy and the magic fluidity of Iranian society. The insertion of cultural politics into the everyday lives of young Iranians in the name of Islamic purity created the reverse attitude and a sentiment of confrontation with the Islamic regime.
•Looking at Iran today, one can say that the ‘growing generational gap between the Islamic state and the Iranian youth, particularly young women, has never been wider. The question to ask would be: if the participants in the Iranian revolution wanted more than anything to be seen and to be heard, why, then, did the revolution degenerate into such violence and tyranny which still plague Iran? Why did people power collapse in on itself, engendering repression, stifling thought and action’?
•These questions remain unanswered, but if one thing is certain, it is that Iran is going towards a political change. This political change is not going to be an easy and a quick one, but it will happen with the same certainty that the revolution happened.
📰 10% reservation quota: SC refuses immediate stay on Act
The petitions in the Supreme Court said the Act violated the Basic Features of the Constitution.
•The Supreme Court on Friday declined to stay operation of the Constitution (103rd Amendment) Act, 2019, which provides 10% reservation in government jobs and educational institutions for the economically backward in the unreserved category, but agreed to an early hearing of the challenge to the law.
•A Bench led by Chief Justice of India Ranjan Gogoi consented to tagging a petition filed by businessman Tehseen Poonawalla, which seeks to have the Act quashed on the grounds that backwardness for the purpose of reservation cannot be defined by “economic status alone”, with other similar petitions filed earlier.
•Mr. Poonawala contends that the quota would be over and above the existing 50% reservation to SCs, STs and Other Backward Classes (OBCs).
•The law was passed by Parliament and received the President’s assent last month. The Act amends Articles 15 and 16 of the Constitution by adding clauses empowering the government to provide reservation on the basis of economic backwardness.
•The petitions in the Supreme Court contend that the Act violates the ‘basic features’ of the Constitution. The petitioners argue that the 50% ceiling limit on quota has been “engrafted as a part of the Basic Structure of the Constitution’s equality code” by the Supreme Court.
Earlier petition
•The Bench has already issued notice on an earlier petition filed by Youth For Equality, which had contended that a nine-judge Constitution Bench in the Indira Sawhney case had already settled the law that economic backwardness cannot be the sole basis for reservation.
•The plea had argued that the Act was “vulnerable” and negates a binding judgment of the top court.
•The petitioners have contended that the amendments exclude the OBCs and the SC/ST communities from the scope of the economic reservation. This, they said, “essentially implies that only those who are poor from the general categories would avail the benefits of the quotas”. They have alleged that the high creamy layer limit of ₹8 lakh per annum ensures that the elite capture the reservation benefits.
•Further, the petition contended that the Supreme Court had settled the law that the “State’s reservation policy cannot be imposed on unaided educational institutions, and as they are not receiving any aid from the State, they can have their own admissions provided they are fair, transparent, non-exploitative and based on merit.”
📰 U.S. may end zero-tariffs for India
The latest downturn in trade ties was India’s new rule on FDI in e-commerce
•India could lose a vital U.S. trade concession, under which it enjoys zero tariffs on $5.6 billion of exports to the United States, amid a widening dispute over its trade and investment policies, people with close knowledge of the matter said.
GSP withdrawal
•A move to withdraw the Generalised System of Preferences (GSP) from India, the world’s largest beneficiary of a scheme that has been in force since the 1970s, would be the strongest punitive action against India since President Donald Trump took office in 2017, vowing to reduce the U.S. deficit with large economies. Mr. Trump has repeatedly called out India for its high tariffs. Indian Prime Minister Narendra Modi has courted foreign investment as part of his Make-in-India campaign to turn India into a manufacturing hub and deliver jobs to the millions of youth. Mr. Trump, for his part, has pushed for U.S. manufacturing to return home as part of his Make America Great Again campaign. The trigger for the latest downturn in trade ties was India’s new rules on e-commerce that restrict the way Amazon.com Inc. and Walmart-backed Flipkart do business in a rapidly growing online market set to touch $200 billion by 2027.
•That, coming on top of a drive to force global card payments companies such as Mastercard and Visa to move their data to India and the imposition of higher tariffs on electronic products and smartphones, left a broader trade package the two sides were working on through last year in tatters.
•The GSP was tied to the trade package and since that deal had slipped further away, the U.S. was considering withdrawing or scaling back the preferential arrangement, people familiar with the matter said.
📰 Government introduces Bill on northeast
The amendment will impact one crore tribal people in Assam, Meghalaya, Tripura and Mizoram.
•The government quietly introduced a Constitution Amendment Bill in Rajya Sabha on Wednesday to increase the financial and executive powers of the 10 Autonomous Councils in the Sixth Schedule areas of the northeastern region. The amendment will impact one crore tribal people in Assam, Meghalaya, Tripura and Mizoram.
•The Bill is one of the legislations announced in the past month in the wake of protests in the region following the passage of the Citizenship Amendment Bill, 2019, in the Lok Sabha. A senior government official said The Constitution (125th Amendment) Bill, 2019 was introduced amid din on February 6 in Rajya Sabha.
•“A call was taken to introduce in the Rajya Sabha so that the legislation remains alive even after the House has adjourned sine die. Introducing it in the Lok Saha would have meant that the Bill’s life is co-terminus with that of the term of the Lok Sabha, which will see the last sitting of the current House on February 13,” said the official.
•The proposed amendments provide for elected village municipal councils, ensuring democracy at the grassroot level.
•The village councils will be empowered to prepare plans for economic development and social justice including those related to agriculture, land improvement, implementation of land reforms, minor irrigation, water management, animal husbandry, rural electrification, small scale industries and social forestry.
•The Finance Commission will be mandated to recommend devolution of financial resources to them, an official statement said.
•The Autonomous Councils now depend on grants from Central ministries and the State government for specific projects. At least one-third of the seats will be reserved for women in the village and municipal councils in the Sixth Schedule areas of Assam, Mizoram and Tripura after the amendment is approved.
•The official said the fate of the Citizenship Amendment Bill, 2019, was not known. It was passed by the Lok Sabha but has to be passed by the Rajya Sabha in the current session to become a law.
•Assam and other States like Meghalaya, Nagaland, Tripura and Mizoram have been protesting against the Bill that would make it possible to give Indian citizenship, mostly to illegal Hindu migrants from Bangladesh in Assam, who came after March 1971, in violation of the 1985 Assam Accord.
📰 Medical devices to be treated as drugs
•The Centre in a notification on Friday said that medical devices — all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators — will be treated as drugs for human beings with effect from April 1, 2020.
•The decision was taken in consultation with the Drugs Technical Advisory Board.
‘Implementation delay’
•“Majority of medical devices are completely unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework which is important from a patient safety perspective. We welcome this step. However we are disappointed about the delay with which the notification takes effect,” said Malini Aisola of All India Drug Action Network.
•She added that it also sends mixed messages because the Government is deliberating a roadmap for brining new and separate regulatory framework for devices.
•Meanwhile after the first stakeholders meeting of The Central Drugs Standard Control Organisation(CDSCO) here on Friday on roadmap for regulation of medical devices with stakeholders of the industry Pavan Choudary,chairman,Medical Technology Assocition of India said: ““Since substantial expertise and experience lie with CDSCO in regulating this sector, the medical device sector feels that it would be best that the authorship of the agenda and the road map stays with them. This would also prevent any duplication.”
•He added: “As this is a technology and capital intensive sector, growth in indigenous manufacturing is a function of maturity of technological ecosystem, ability to attract capital particularly from legacy investors, market attractiveness & ease of doing business. We, therefore think, that to judge the quality of regulations by the yardstick of how much import substitution these have delivered is unfair. A time bound regulatory roadmap was discussed,” said
📰 Startups to be listed for angel tax exemption
Notification to be issued in a few days
•The Department for Promotion of Industry and Internal Trade (DPIIT) and the Central Board of Direct Taxes (CBDT) on Friday agreed to compile a list of startups eligible for angel tax exemption, based on their audited financial statements and income tax returns of the previous year. The notification is likely be issued in a couple of days.
•The government also decided to raise the maximum time limit below which a firm would be deemed eligible for angel tax exemption to 10 years from the earlier seven, a member of the committee set up to look into the issue said, speaking on condition of anonymity.
•Further, the paid-up share capital threshold below which startups would be eligible for an exemption has been set at ₹25 crore. In cases where the investment exceeds ₹25 crore, the firms would be eligible for exemption if the angel investors can prove a net worth of ₹2 crore or more in the previous financial year. For investments below ₹25 crore, no questions would be asked.
•Angel tax is imposed on the excess share capital raised by an unlisted firm, over and above the fair market value of its shares.
•This tax usually impacts startups and the angel investments they attract. While aimed at curbing money-laundering, the angel tax has also resulted in a large number of genuine startups receiving notices from the IT Department.
•Startups would have to furnish three types of documents in order to be registered with the government: (i) audited financials for the previous year, (ii) IT returns for the previous year, and (iii) a self-certified declaration. The declaration is to certify that the firm does not have ownership or investments nor plans to deploy the angel investment in real estate holdings of any kind and assets, including premium cars of value above ₹10 lakh, gold and art, diamonds, precious metals or jewellery of any kind, listed or unlisted securities directly or indirectly via equity mutual funds, or art and coins.
•The declaration has to also acknowledge that if the company possesses any of these items, then the exemption granted from Section 56(2)(viib) would be revoked with retrospective effect.
•Once these documents are furnished, the DPIIT would have to validate them, and then submit the name and PAN of all these companies to the CBDT. The CBDT would then set up a mechanism where such recognised startups do not get notices under Section 56(2)(viib).
•“The DPIIT and the CBDT have agreed to these and the notification will be issued shortly,” the member told The Hindu. “They also have agreed to increase the length of operation clause and have also increased the share capital clause to ₹25 crore.”
•The DPIIT was earlier considering defining a startup eligible for exemption from the angel tax if the aggregate amount of paid-up share capital and share premium after the proposed issue of shares did not exceed ₹10 crore. This has now been raised to ₹25 crore.
•The CBDT, however, said that it could not halt the proceedings in cases where the startups had already been sent a notice by the income tax department.
•“Regarding the cases where notices have already been sent, the government officials are saying they are going to instruct the relevant authority to close the case as soon as possible, and also take into consideration the fact that the company is registered as a startup with the government,” the committee member said.
📰 Surveying India’s unemployment numbers
India’s labour participation rate, very low by world standards, fell sharply after demonetisation. Women bore the brunt
•Monthly measurement of the unemployment rate is one of the requirements of the Special Data Dissemination Standard (SDDS) of the International Monetary Fund (IMF). The SDDS — India was one of the early signatories —was established in 1996 to help countries access the international capital markets by providing adequate economic and financial information publicly. India complies with many requirements of the SDDS, but it has taken an exception with respect to the measurement of unemployment.
•The Government of India does not produce any measure of monthly unemployment rate, nor does it have any plans to do so. Official plans to measure unemployment at an annual and quarterly frequency is in a shambles. This does not befit India’s claims to be the fastest growing economy and as the biggest beneficiary of a famed demographic dividend.
•The Centre for Monitoring India Economy (CMIE), a private enterprise, has demonstrated over the past three years that fast frequency measures of unemployment can be made and that seeking an exception on SDDS compliance is unnecessary.
Higher frequency survey
•The CMIE decided to fill India’s gap in generating fast frequency measures of household well-being in 2014. In its household survey, called the Consumer Pyramids Household Survey (CPHS), the sample size was 172,365 as compared to that of the official National Sample Survey Organisation (NSSO), which was 101,724. In both surveys, the sample selection method has been broadly the same.
•The CPHS is comprehensive, surveying its entire sample every four months. Each survey is a wave. The CPHS is also a continuous survey, and so, for example, three waves are completed in a year. The CMIE’s CPHS thus has a much larger sample and is conducted at a much higher frequency than the NSSO’s.
•Further, the CPHS is conducted as face-to-face interviews necessarily using GPS-enabled smartphones or tablets. Intense validation systems ensure high fidelity of data capture. All validations are conducted in real-time while the teams are in the field. The data capture machinery ensures delivery of high quality data in real time obviating the need for any further “cleaning”, post field operations.
•Once the data is collected and validated in real-time, it is automatically deployed for estimations without any human intervention.
•In 2016, the CMIE added questions regarding employment/unemployment to the CPHS. Since then, the CMIE has been generating labour market indicators regularly and making these freely available for public use (https://bit.ly/2OxLAs4).
•A difference between the CPHS and the NSSO surveys is the reference period of the employment status of a respondent. While the NSSO tries to capture the status for an entire year and for a week, the CPHS captures the status as on the day of the survey. This could be as one of four factors: employed; unemployed willing to work and actively looking for a job; unemployed willing to work but not actively looking for a job, and unemployed but neither willing nor looking for a job.
•Since the recall period in the CPHS is of the day of the survey (or the immediate preceding day in the case of daily wage labourers) and the classification is elementary, the CPHS has been able to capture the status fairly accurately with no challenges of the respondent’s ability to recall or interpret the status. In contrast, the NSSO’s system is quite complex.
•The large CPHS sample is distributed evenly across rural and urban regions for every week of the execution cycle of 16 weeks of a wave. It is this machinery that enables us to understand the Indian labour market with fast-frequency measures. So what do these fast-frequency measures tell us?
Key findings
•The most important message from the data is that India’s labour participation rate is very low by world standards and that even this low participation rate fell very sharply after demonetisation. The average labour participation rate was 47% during January-October 2016. The world average is about 66%.
•Immediately after demonetisation in November 2016, India’s labour participation rate fell to 45%; 2% of the working age population, i.e. about 13 million, moved out of labour markets. That is a lot of people who were willing to work who decided that they did not want to work any more.
•The data show that it was not the employed who lost jobs and decided to stop working. The employed mostly retained their jobs. But it was largely the unemployed who decided that the labour markets had been so badly vitiated after demonetisation that they gave up looking for jobs any further. In short, they lost hope of finding jobs in the aftermath of demonetisation.
•As more and more unemployed left the labour market, the unemployment rate fell. This is because the unemployment rate is the ratio of the unemployed to the total labour force. This fall gave misleading or at least confusing signals, almost implying that the unemployment rate was falling in a positive sense. In reality it was a reflection of an exodus of the unemployed from the labour markets — a fall in the labour participation rate. And this underlines the much greater importance of the labour participation rate.
On female labour
•Specifically, India’s female labour participation rate is very low. Official statistics have always shown that India’s female labour participation rate is low and falling. Researchers have shown that this fall is because of rising household incomes that reduce the need for women to join the labour force; increased enrolment in higher education by women which delays their entry into the labour force, and cultural and security factors that keep women away from the labour market in India. Further, it is evident that employers are also biased against hiring women.
•The CPHS shows that the situation with respect to women’s participation in the labour force is extremely poor — much poorer than what the official agencies tell us. The entire brunt of demonetisation was borne by women. Their labour participation fell sharply while that of men did not.
•After the demonetisation jolt came the Goods and Services Tax shock of July 2017 that drove away small enterprises which could not compete in a tax-compliant environment out of business. This caused a substantial loss of jobs. Preliminary estimates suggest that employment shrunk by 11 million in 2018. The brunt of this was again borne largely by women. But men too were also impacted.
•Male labour participation rate was 74.5% in 2016. This dropped to 72.4% in 2017 and then to 71.7% in 2018. In contrast, female labour participation was as low as 15.5% in 2016 which dropped to 11.9% in 2017 and then 11% in 2018. Urban female labour participation rates fell faster than rural female participation. In urban India it dropped from 15.2% in 2016 to 10.5% in 2018. The corresponding values for rural women were 15.6% and 11.3%, respectively.
•Although female labour participation is substantially much lower than male participation, the few women who venture to get employment find it much more difficult to find jobs than men. The unemployment rate for men was 4.9% in 2018 and that for women in the same year was much higher — 14.9%.
•This higher unemployment rate faced by women in spite of a very low participation rate indicates a bias against employing women. Drawing women into the labour force by removing the impediments they face to at least bring their participation levels close to global standards is critically important for India to gain from the demographic dividend opportunity it has. This window of opportunity is open only till 2030. By not using a good data monitoring machinery, the Indian government is keeping both itself and the citizenry in the dark.
📰 Vet institute, ambulances mooted in Rs. 98 crore lion conservation plan
Centre and Gujarat govt. announce project that includes a wildlife crime cell
•Three months after at least 20 lions in Gujarat succumbed to a virus, the Centre and the Gujarat government have announced a Rs. 97.85 crore Asiatic Lion Conservation Project at a press conference here on Friday.
•A key outcome of the project is to have a dedicated veterinary institute, “lion ambulances”, and back-up stocks of vaccines that may be required. There are close to 600 lions in Gujarat, according to State forest officials at the meeting. However, there has been no move yet to translocate lions to a location outside Gujarat.
•“There is a committee of experts from both States examining the suitability of Madhya Pradesh as a potential lion reserve. Secondly, we also have to comply with certain guidelines of the International Union for Conservation of Nature (on selecting suitable habitat, translocation),” said Rajiv Kumar Gupta, Additional Chief Secretary, Gujarat.
No progress
•The Kuno-Palpur Wildlife Sanctuary in Madhya Pradesh was identified to be the most suitable for reintroducing the species, according to a Supreme Court-appointed technical expert committee, but there has been no progress on the proposal.
•The SC in April 2013 had ordered the translocation of some lions from Gujarat to Madhya Pradesh within six months, but this hasn’t happened. This was ordered after several recommendations by expert groups, including the Wildlife Institute of India. It emphasised that the long-term survival of the lion as a species was best served if they could be present outside Gujarat, too, so that they are protected against, say, a forest fire, a disease, or calamities.
•While the lion deaths of last year brought these questions to the fore, they also pointed to the stark reality of lion numbers rising to an extent that several of them were now found outside protected areas and involved in human-animal conflict as well as in increasing contact with domestic animals as well as feral dogs, from where they could have contracted the virus.
•“We are not closed to the idea and will do anything required for the protection of this species,” said Environment Minister Harsh Vardhan.
•The Gujarat government, on its part, has envisaged a ‘Greater Gir’ that includes, other than the existing Gir National Park, sanctuaries in Girnar, Pania and Mitiyala.
•Key aspects of the conservation project include undertaking “habitat improvement” measures, making more sources of water available, creating a wildlife crime cell, and a task force for the Greater Gir region.
•It would also involve having in place a GPS-based tracking system, which would look at surveillance tracking, animal and vehicle tracking. There would also be an automated sensor grid that would have magnetic sensors, movement sensors and infra-red heat sensors.
📰 TB survivors challenge patent to end J&J monopoly
•Two tuberculosis survivors from India and South Africa have challenged a patent to prevent pharmaceutical giant Johnson & Johnson (J&J) from extending its monopoly on bedaquiline, one of the two newest anti-TB drugs in 50 years.
•Mumbai’s Nandita Venkatesan and Cape Town’s Phumeza Tisile are both survivors of drug resistant TB, who lost their hearing because of the toxicity of anti-TB treatment. They are now advocating for a wider rollout of newer drugs like bedaquiline over other painful injections and drugs with severe side effects.
•“With this patent challenge, we want to stop an extension of the patent monopoly that will continue to block people from accessing more affordable generic versions of bedaquiline,” Ms. Venkatesan said in a statement.
•The patent challenge has been filed with support from Médecins Sans Frontières (MSF). “Despite the benefits of the drug, high prices remain a barrier. J&J recently announced a reduced price of $400 for six months of bedaquiline treatment for South Africa and countries procuring the drug through the Global Drug Facility, but this falls short of making the drug affordable in all countries affected by the DR-TB epidemic,” a statement from the MSF said.
•The statement also said the J&J patent application being challenged is for the salt form of bedaquiline, which does not merit patenting under India’s patent law. If granted, J&J’s monopoly on bedaquiline would be extended from 2023 to 2027, delaying entry of generics by four additional years.
•A J&J spokesperson said the company is committed to ensuring that bedaquiline reaches as many patients as possible, and it is a committed partner in India’s efforts to combat TB. “The patent application in question – for the formulation of bedaquiline – was filed in 2007, and became publicly available in 2008, as part of standard procedures when developing new medicines. The application was first considered by the Indian Patent Office in 2012 and remains under review. A formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023,” the spokesperson said.
•The spokesperson also said since the introduction of bedaquiline in India, J&J has donated more than 10,000 courses to support the government’s efforts to scale up access. “Beyond providing access to bedaquiline, we have also supported efforts to improve diagnostic capacity, train health workers on the clinical management of TB, and raise awareness of TB at the community level.”
