Front Page / NATIONAL
Front Page / NATIONAL
 Smog could return’
The heavy blanket of smog that enveloped Delhi for days after Diwali could return soon as the constant sources of pollution have remained largely the same, experts said
Return of the Smog
If wind-speed drops, cooler temperatures in the weeks ahead could provide a favorable setting for the smaug to return(For the LOTR fans out there J)
Not much have been done to curtail any of the sources that lead to the poisonous smog to develop in November
Burning of agricultural residue
A factor that contributed to heavy particulate matter concentration during the recent smog episode was burning of agricultural residue in neighbouring States. The government is yet to look at a long-term plan to prevent the practice
Other sources of pollution, including industries, power plants and vehicles, have also remained largely untouched
In winter months pollution worsens because of the cooler temperatures that prevent the dispersion of particulate matter and gases. There will have to be sustained efforts and systemic changes, including in public transport and walking tracks, in order to tackle this problem once and for all.
The entire discussion revolves around taking short term measures like banning construction activity or odd-even scheme but all these are not going to help in the long run. A sustained effort over a period of time will ensure that Delhi is able to breathe clean air once again.
 Agni-I missile test-fired
The Strategic Forces Command (SFC) fired the missile positioned on a massive truck called a road-mobile launcher.
What has happened?
The strategic missile, Agni-I, was test-fired at 10.08 a.m. on Tuesday from the Wheeler Island, off Damra village on the Odisha coast
- The launch was undertaken as periodic training activity by SFC to further consolidate operational readiness
- From the missile’s lift-off to its reaching a targeted area in the Bay of Bengal, the mission lasted about 10 minutes.
- There are five Agni variants from Agni-I to Agni-V which form the bulwark (defensive wall) of India’s nuclear deterrence programme
Agni missiles have been designed & developed by DRDO
 No complacency on Zika
The World Health Organisation has declared that the Zika virus no longer constitutes a public health emergency of international concern. This brings to an end the heightened global focus on the virus that has caused about 2,300 confirmed cases of microcephaly (a birth defect manifesting in a smaller head size) since May 2015.
The WHO had declared the Zika virus a public health emergency on February 1, considering the high number of neurological disorders reported in Brazil and a similar cluster in French Polynesia in 2014.
Why Zika was declared a public health emergency?
Reasons given were:
- Unknown causal link between the virus and microcephaly and neurological complications
- The possibility of its global spread
- Lack of vaccines and diagnostic tools
- The lack of immunity to the virus in newly affected countries
Note: The link between Zika virus and Microcephaly was established in May
- There is now cure
- Scientists have been able to find routes of transmission
- Zika has spread to 67 countries
Sustained Research & effort
- The WHO Emergency Committee has called for sustained research and dedicated resources to address the long-term challenges posed by babies born with microcephaly.
- Medical journals should continue to provide free and immediate access to papers on the Zika virus, which played a crucial role in information-sharing.
WHO may have declared Zika to be no longer a public emergency of global concern but this should not lower the efforts needed to develop effective vaccines, diagnostic tests and creating awareness against it.
For more info: Zika has been covered in detail under Mains Article 2016
 Pitching reform at the BCCI
Not many can complain about the manner in which cricketing matters are being managed, but the intransigence shown by the office-bearers of the Board of Control for Cricket in India in not constructively accepting the reforms recommended by the Supreme Court-appointed R.M. Lodha Committee is getting to be tiresome.
Article gives us nothing new in term of points. The news detailing the appointment of Observer by Lodha Panel has already been covered in the brief dated 22nd November 2016
Just give it a go through.
 Generics vs big pharma, reloaded
Indian Pharmaceutical Alliance (IPA) has, in a letter to Government of India, strongly condemned the proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, as this would result in a long and damaging data exclusivity
What is data exclusivity?
Data exclusivity is an independent intellectual property right and should not be confused with the protection provided by other rights, especially patents.
- It provides the holder with specific rights, namely that the data generated by the holder may not be referred to or used by another person or company for a specific period of time.
- It does not prevent another company from generating the data. Thus, the right is quite limited in the first instance.
- However, it has been considered to be of critical importance by countries to provide the necessary incentives for companies to generate the necessary data that accompanies registrational packages for medicinal products
The Agreement on Trade-Related Intellectual Property Rights (the “TRIPs Agreement”) specifically recognizes the “protection of undisclosed information” as being a category of intellectual property subject to protection.
- The intellectual property right reference in Article 39.3 of TRIPS is commonly referred to as “data exclusivity” in the U. S. and “data protection” or “regulatory data protection” in the European Union.
Why data exclusivity is necessary?
In order to demonstrate a drug’s efficacy and safety for its intended therapeutic use, it is necessary for the originator of the drug to conduct extensive testing on animals and humans in pre-clinical and clinical trials as well as toxicology, manufacturing feasibility and other scientific studies.
The results of these tests and studies, which are proprietary, are contained in a registration report that is submitted to governmental authorities to obtain marketing approval for the drug.
- Cost and effort: The generation of this confidential registration data involves a very substantial amount of time and expense for the originator; the entire drug development process from discovery to marketing may take as long as fifteen years and cost, on average, $500 million in industrialized countries.
- The registrational data are provided to the authorities in confidence and are not meant to be referred to by third parties. If these data were immediately available to third parties, there would be no incentive for a company to generate these data in the first instance, unless the investment in terms of both time and costs were protected by another means
- It is important that governments protect the confidentiality of these data against its unauthorized use or disclosure in order to protect the proprietary interests of scientists and others and to maintain the economic incentives for further pharmaceutical research and development
Why, a period of 4 years is imposed on data exclusivity?
Because of a concern for avoiding repetitive tests and trials on animals and human, governments have sought to limit the originator’s proprietary data rights. Therefore, governments have acknowledged the right of data protection for a certain fixed period of time After the period has expired, reference to the data is permitted by generic companies.
- This compromise is viewed as protecting the investment of the originator, while at the same time preventing unnecessary repetitive tests and trials
- In India this period is 4 years as of now.
Difference between a patent and Data exclusivity
As opposed to a patent right, which gives the right holder the right to exclude others from making, using, selling, offering for sale, or importing the patented product, the protection that governments must accord proprietary test data does not, per se, exclude the copier from running its own tests and submitting the results to the regulatory authorities.
- Assuming the absence of any intervening patents, a generic alternative may still receive marketing approval, provided that the generic manufacturer conducts its own pre-clinical and clinical trials and independently seeks marketing authorization by the regulatory bodies
Now, let us take a look as to what is this whole issue all about.
Under the Drugs & Cosmetics Act (DCA), a new drug continues to remain “new” even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses “newness” after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval.
- It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India
At present, a generic drug maker can get his drug approved upon a simple showing of bio-equivalence i.e. that the claimed molecule is the same as the one already approved. This bio-equivalence must be demonstrated through rigorous studies/data
- So, at present all generic drug makers in India wait for the 4 year period to get over rather than conducting expensive clinical trials afresh.
- Ethical issue: A generic drug maker repeating the entire clinical trial and testing process again for the same molecule would be unethical as the whole process involves animal studies and human volunteers
Problem with DCA
Act is not very clear on the kind of studies/data that a generic applicant is meant to submit to show bio-equivalence
Problem with state regulators
As studies/data norms are not clear in DCA, hence, a number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State
- Therefore, drug manufacturers in India opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance
Problem with DCGI
A parliamentary committee reportin 2012 found that in the vast majority of cases, the DCGI doesn’t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad “public interest” exception.
A lax regulatory regime
Author poses few questions,
- Why have this four-year or 10-year time lag at all for generic drug approval?
- Shouldn’t generic drugs be approved on Day One, so long as they are able to demonstrate (through bio-equivalence studies and the like) that they are as robust as the new drug that has already been approved once?
- Why maintain this legal fiction that a drug will remain “new” even after it has been validly approved once (for up to four years or 10 years as the case may be)?
Author concludes by saying that a lax regulatory regime in the drug sector poses a far more dangerous scenario then pollution. Government should take upon itself to reform and rid this sector of its glaring gaps that are exploited routinely by drug majors.
 The widening class divide
Children from the RTE quota are often left feeling small as equality seems to be lost in monetary disparity.
Article is a ground level commentary on the prejudice that is faced by students admitted to schools under Right to Education Act (RTE Act). Author lists various ways in which they are discriminated against like,
- In some private schools they are made to sit in separate rows under separate teaching sections
- Not allowed to participate in annual functions
- Parents are made to pay over and above what they are required to in the name of smart-school fee, picnic fee and other miscellaneous fees
- Not allowed to sit in tests because their parents are unable to pay fees
- Schools feel that they are doing some sort of charity
Right to Education
Constitutional provision: The Constitution (Eighty-sixth Amendment) Act, 2002 inserted Article 21-A in the Constitution of India to provide free and compulsory education of all children in the age group of six to fourteen years as a Fundamental Right in such a manner as the State may, by law, determine.
RTE: The Right of Children to Free and Compulsory Education (RTE) Act, 2009, which represents the consequential legislation envisaged under Article 21-A, means that every child has a right to full time elementary education of satisfactory and equitable quality in a formal school which satisfies certain essential norms and standards.
- Article 21-A and the RTE Act came into effect on 1 April 2010. The title of the RTE Act incorporates the words ‘free and compulsory’
- ‘Free education’ means that no child, other than a child who has been admitted by his or her parents to a school which is not supported by the appropriate Government, shall be liable to pay any kind of fee or charges or expenses which may prevent him or her from pursuing and completing elementary education
- ‘Compulsory education’ casts an obligation on the appropriate Government and local authorities to provide and ensure admission, attendance and completion of elementary education by all children in the 6-14 age group
With this, India has moved forward to a rights based framework that casts a legal obligation on the Central and State Governments to implement this fundamental child right as enshrined in the Article 21A of the Constitution, in accordance with the provisions of the RTE Act
Note: Education is under Concurrent list
Author concludes by saying that if RTE act is not embraced in spirit by parents, school teachers, and schools themselves, then its legacy will be overshadowed by prejudice, discrimination and a reaffirmation of the class divide.
For more info on RTE: Visit this link
 Rerailing the Indian Railways
In managing safety, the emphasis should be on reforming the system rather than firefighting.
Author, a former member of railway board, has tried to enlist some possible measures to avoid such accidents in future.
Online feedback on unsafe practices
Author says that in modern times where communication channels are plenty, railways can adopt the British rail model wherein there is a free flow of information from the lowest to the highest levels about any deviations from the accepted norms or practices so that corrective action can be initiated promptly.
- The objective should be to get real-time feedback from individuals regarding “near misses” or error-promoting conditions which would normally not be reported through usual channels, and to use this information to enhance safety
- Also, confidentiality of the person making the report needs to be maintained.
Cost benefit analysis of investments
Author says that a cost benefit analysis should be done after investments in safety are done. He gives the example of the
- sanction of a Special Railway Safety Fund in 2001 amounting to Rs.17,000 crore (spread over five-six years) consequent to recommendations of the high-level safety committee under Justice H.R. Khanna
- The implementation of the Corporate Safety Plan in 2003
He says that due to above steps there was a perceptible reduction in the total number of accidents, particularly derailments, with the accident rate declining from about 0.44/million train kilometres in 2003 to about 0.13/million train kilometres by 2013 but why this reduction was seen has never been studied. This needs to be changed wherein a proper periodic evaluation is done of the benefits arising out of safety investments
Making the reports public
Author says that in order to assuage public sentiment that nothing is ever going to come out of an enquiry ordered after an accident, a summary of the findings of major accidents and the follow-up action taken cannot be put in the public domain. The U.S. Department of Transportation regularly uploads its reports on train accidents on its website
 Demonetisation’s positives unlikely to be strong: Fitch
Fitch Ratings said that the government’s decision on demonetisation that had created a cash crunch would constrain economic activities in the short-term forcing the credit rating agency to cut its GDP forecast for the fourth quarter.
Fitch ratings: It is an international credit rating agency like Moody’s and Standard & Poor’s
Observations made by Fitch ratings
- Increased impact: The impact on GDP growth will increase the longer the disruption continues
- No likely change in ratings: Benefits from the withdrawal of high-denomination currencies were unlikely to be enduring enough to result in a change in the outlook for India’s sovereign rating
- Increased government revenue: The move has the potential to raise government revenue and encourage bank lending
- Cashless transactions not incentivized: No new incentives to for people to avoid cash transactions. The informal sector could soon go back to business as usual
- Positive impact depends on future withdrawals: The positive impact on funding conditions will depend on deposits remaining in banks beyond the next few months. There is nothing to prevent them being withdrawn again
- Asset quality: Demonetisation could also affect the ability of borrowers in sectors that rely on cash transactions to service their loans, with negative effects on bank asset quality, which is why the RBI has temporarily allowed banks to give small borrowers more time to repay loans.
 ‘India’s wealth rises, as does disparity’
Article talks about the observations made in the 7threport on global wealth by Credit Suisse
Important observations made in the report
- Increasing disparity: The total quantum of wealth is rising in India but so is the disparity between those who have wealth and those deprived of it.
- Property & Real estate dominate: Wealth in India is dominated by property and other real estate that make up 86 per cent of its estimated household assets
- Millionaires: The number of millionaires is projected to increase by 9.5 per cent in the next five years to 2.8 lakh in 2021
- Low personal debts: personal debts are estimated to be 9 per cent of gross assets in India, much lower than in most developed countries
- Uneven growth: While wealth has been rising in India, growth is uneven. About 96 per cent of the adult population remains at the base of the wealth pyramid with wealth below $10,000, and a small fraction of the adult population (0.3 per cent) has net worth of more than $100,000
Credit Suisse: Credit Suisse Group is a Swiss multinational financial services holding company, headquartered in Zürich, that operates the Credit Suisse Bank and other financial services investments
For more info on the report: Please refer this link
 Fifty days later
Small and medium enterprises in the rural sector may be grievously hurt by the cash rationing.
Problems for farmers
The withdrawal of high denomination notes has frozen transactions in the mandis, and farmers are unable to sell their full produce of fruit and vegetables since buyers don’t have enough cash
- Relief offered:With the Rabi season kicking in, they have now been allowed to use their old Rs 500 notes to buy seeds
- 60 extra days to repay their housing, crop and micro finance loans
Problem that still persists
Author states that the relief and relaxation offered by the government are mostly availed by enterprises in the urban and metro centers, where bank presence is adequate. The smaller businesses are still suffering
Skewed distribution of banks
Despite a focus on financial inclusion over the last 10 years, the spatial distribution of banks and ATMs has remained skewed in favour of urban India. One out of every four ATMs in India is in a metro, and one rural-semi urban bank branch has to serve 12,820 people, compared with a metro and urban bank branch which caters to just 5,348 persons.
MSMEs in India
Only 4% of the total MSMEs are registered in India. Out of that 4%, 45% are located in rural India. Out of unregistered MSMEs around 60% are rural
- Unregistered units are those that do not file business information with the district industries centres in the states.
- Hence, Majority of Micro, Small and Medium Enterprises (MSMEs) are in rural India
What is the definition of MSME?
The Government of India has enacted the Micro, Small and Medium Enterprises Development (MSMED) Act, 2006 in terms of which the definition of micro, small and medium enterprises is as under:
Enterprises engaged in the manufacture or production, processing or preservation of goods as specified below:
- A micro enterprise is an enterprise where investment in plant and machinery does not exceed Rs. 25 lakh;
- A small enterprise is an enterprise where the investment in plant and machinery is more than Rs. 25 lakh but does not exceed Rs. 5 crore; and
- A medium enterprise is an enterprise where the investment in plant and machinery is more than Rs.5 crore but does not exceed Rs.10 crore.
In case of the above enterprises, investment in plant and machinery is the original cost excluding land and building and the items specified by the Ministry of Small Scale Industries
Enterprises engaged in providing or rendering of services and whose investment in equipment (original cost excluding land and building and furniture, fittings and other items not directly related to the service rendered or as may be notified under the MSMED Act, 2006 are specified below.
- A micro enterprise is an enterprise where the investment in equipment does not exceed Rs. 10 lakh;
- A small enterprise is an enterprise where the investment in equipment is more than Rs.10 lakh but does not exceed Rs. 2 crore; and
- A medium enterprise is an enterprise where the investment in equipment is more than Rs. 2 crore but does not exceed Rs. 5 crore.
Employment generation by MSMEs
By unregistered units (which are mostly in rural areas): Over 7 crore of persons are employed in these units
By registered units(which are mostly in urban areas): less than a crore jobs
Why demonetization affects MSMEs most?
- Access to finance: Because even in normal times the access to finance is a problem for them. It is not viable for them to raise funds through equity or debt. Banks only lend to credit worthy SMEs so a large number of MSMEs carry their business either in cash or by borrowing from the informal sector, which is expensive but available without many procedural hassles
Hence, taking out cash from the system is like sucking oxygen for MSMEs
Why MSMEs prefer to deal in cash?
- Funding requirements: Author states that the MSMEs in rural areas have meagre financial demands, explaining why they have preferred to deal in cash. The money, therefore, with such MSMEs is not a part of black money
- Absence of banks: Banks have not yet managed to bring in the remote hinterlands into the financial domain.
- Fear of harassment: Author points out that the fear of harassment by the tax official and petty bureaucracy in the banks also force MSMEs to deal in cash
Author concludes by stating that even a small hiccup in the supply chain leads to a severe shock for MSMEs because except few which act as suppliers to large enterprises, most are located away from urban clusters leading to a liquidity crunch.
 Time for Indian Railways to put safety first
In the light of recent train accident at Kanpur, Uttar Pradesh, the following article tries to bring forth issues plaguing safety within Indian railways and what can be done to alleviate those ills.
- Ridiculously low tariffs: Author states that while tariffs are kept low, new trains are constantly introduced, burdening the track infrastructure to unbearable levels.The low tariffs do not allow the passenger railways to recover its losses and the resources available to enhance safety mechanisms remain minimal
- Human encroachments: Political reasons do not allow railways to remove human encroachments on railway infrastructure which is another source of casualties
- Slow pace of technology adoption: The other major problem with the Indian Railways is the slow pace of technology adoption. The Indore-Patna Express was travelling at a speed of 110km per hour—a speed at which the ICF coaches (manufactured in Integral Coach Factory, Chennai) are not safe due to lack of anti-climbing features. The high-level safety review committee chaired by Anil Kakodkar had recommended switching over from ICF to Linke Hofmann Busch (LHB) coaches in 2012. The task remains incomplete to this date
How LHB coaches could have helped in present tragedy?
The LHB coaches have anti-climbing features which prevent the rolling stock from piling over each other in case of accidents, thus minimizing the number of casualties
- Maintenance of tracks: Indian railways still rely on a large workforce of trackmen for the maintenance of track infrastructure. In the backdrop of the recent accident, various efforts underway to incorporate technology to do this job must be accelerated
- Swachh Rail–Swachh Bharat programme: Author states that installation of bio-toilets has a safety angle too as the direct discharge of human waste has several serious safety implications arising out of corrosion of rails and related hardware as well as poor maintenance of under carriage equipment due to inhuman unhygienic conditions
- Independent regulator: Author says that railways need an empowered safety regulator which is not merely a part of the overarching regulator. At present the Commissioner of Railway Security (CRS), though independent, is with the Union ministry of civil aviation
 Women powering a clean future
There is a clear link between energy access and women’s economic empowerment and well-being.
Article talks about clean energy access to women and how it can lead to an improved condition for women and the country as a whole.
Sustainable Development Goals
The Sustainable Development Goals (SDGs) are a new, universal set of goals, targets and indicators that UN member states will be expected to use to frame their agendas and political policies over the next 15 years.
- The Sustainable Development Goals (SDGs), are officially known as “Transforming our world: the 2030 Agenda for Sustainable Development”. There are 17 Sustainable Development Goals, associated 169 targets and 304 indicators.
- SDG include the following goals:
- End poverty in all its forms everywhere
- End hunger, achieve food security and improved nutrition and promote sustainable agriculture
- Ensure healthy lives and promote well-being for all at all ages
- Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all
- Achieve gender equality and empower all women and girls
- Ensure availability and sustainable management of water and sanitation for all
- Ensure access to affordable, reliable, sustainable and modern energy for all
- Promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all
- Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation
- Reduce inequality within and among countries
- Make cities and human settlements inclusive, safe, resilient and sustainable
- Ensure sustainable consumption and production patterns
- Take urgent action to combat climate change and its impacts
- Conserve and sustainably use the oceans, seas and marine resources for sustainable development
- Protect, restore and promote sustainable use of terrestrial ecosystems, sustainably manage forests, combat desertification, and halt and reverse land degradation and halt biodiversity loss
- Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels
- Strengthen the means of implementation and revitalize the global partnership for sustainable development
The 22nd meeting of the Conference of Parties was held at Marrakech in Morocco. It was the follow-up meet to the COP21 where the landmark Paris agreement was signed.
- COP22 resulted in Action Proclamation for our climate and sustainable development
Energy access & women empowerment
Article says that there is a clear link between energy access and women’s economic empowerment and well-being.
Unpaid work: Article mentions that in India women still spend up to 5 hours a day collecting fuel for cooking, as part of their unpaid, unrecognized and unaccounted care work. Time women spend in doing this work restricts their opportunities for education, paid employment and economic advancement.
Solution: Improving energy access would reduce the burden on women
Health perspective: The usage of biomass for fuel leads to respiratory problems as burning biomass fuel releases harmful gases.
Solution: Clean cooking fuels such as liquefied petroleum gas (LPG), biogas and other options such as solar energy could help eliminate the hazards of indoor air pollution in the nearly 140 million Indian households that rely on open fires and biomass for cooking.
Prone to violence: Women often venture out to collect firewood in remote, isolated and difficult geographic terrains, and are therefore more vulnerable to violence
Benefits of improving clean energy access to women
- Gains for the ecosystem: Access to energy for women also results in positive gains for the ecosystem. For example, the electrification of rural communities can result in a 9 percentage point increase in female employment, and a staggering 23% increase in the probability of rural women working outside the home
- Valuable addition to economy: Clean energy access would free women from the burden of unpaid housework thus enabling them to participate in other useful employment avenues. According to a recent study by the McKinsey Global Institute, empowering women to participate in India’s economy on an equal basis with men would add $3 trillion to the nation’s economy by 2025.
- Improvement in social conditions:Women invest 90% of their income back into their families and their welfare which has a lasting effects for generations to come.
The government’s Ujjwala scheme, which provides LPG connections at reduced rates to women from Below Poverty Line households, is a useful example.
Women’s Entrepreneurship for Sustainable Energy
The ministry of new and renewable energy (MNRE) and UNEP, at COP21 in Paris, launched the new flagship programme on “Women’s Entrepreneurship for Sustainable Energy”
- The programme is supported by the UK’s department for international development, and will be implemented in four states—Madhya Pradesh, Nagaland, Rajasthan and Uttar Pradesh—in 2017
- The programme seeks to address barriers holding up women entrepreneurs, enable women’s participation and leadership in energy policies, and the productive use of sustainable energy
- At COP22, UN unveiled its partnership with MNRE, GOI and United Nations Environment Program (UNEP) wrt the above programme