1.Generic medicines in a digital age (The Hindu)
2.Bhutan’s exit from BBIN (The Hindu, First post)
3.New Visa rules and its impact (The Hindu, Times of India)
4.How Bidar beat back the drought (The Hindu)
1.Generic medicines in a digital age (The Hindu)
Synoptic line: It throws light on issue of providing safe medicines along with maintaining affordability and accessibility. (GS paper III)
- Country’s apex medical regulator has warned the doctors of action if they fail to adhere to its guideline on prescribing the drugs only in generic names and writing prescriptions legibly.
- However, it is needed to be seen whether all the issues of accessibility and patient’s safety are taken care off before making any such move.
- The Medical Council of India (MCI), an apex body that supervises medical education in the country, already has a recommendation in place wherein they have asked doctors to preferably prescribe generic drugs.
- Now MCI had reiterated its 2016 directive, few days after Prime Minister stressed on putting in place a legal framework to ensure that the doctors prescribe low cost generic medicines to the patients.
- Prescribing a generic medicine means doctors are supposed to write the name of the salt and not the brand name under which the salt is manufactured and marketed.
- The Jan Aushadhi programme, under which the government provides essential medicines at reasonable rates at specially established shops, is also being reinforced.
But there are certain impending issues to be taken care before taking any such step!
- It denotes similarity between two drugs meaning that they both have the same effect on the patient. Bioequivalence means that two drugs release their active ingredient into the bloodstream in the same amounts and at the same rate.
- When assessing how well a generic drug works, scientists evaluate its bioequivalence to the name-brand version.
- For a generic drug to get the U.S. Food and Drug Administration’s (FDA) stamp of approval, the manufacturer must prove that it is bioequivalent to the name-brand version. Moreover, The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory.
- However, until earlier this month, India mandated BE studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies.
- As a welcome move, now Ministry of Health finally amended the Drugs & Cosmetics Rules to make BE testing of all highly soluble drugs compulsory. However, it is a question as what will accompany in case of generics approved prior to recent decision?
- According to the government’s most recent survey of the quality of drugs in India, 10% of all drugs from ‘government sources’ tested NSQ, or not of standard quality. A NSQ drug will compromise patient health.
- Moreover, did the manufacturers of these generic drugs voluntarily conduct BE studies? We do not know. If there is no proof of bioequivalence, should doctors be forced to make this choice?
- Hence, If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product.
- At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug’s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory.
- The challenge for the government is to balance its policy objectives of taking the power of the doctor away to prescribe brand name drugs with the reality that generic drugs in India are of questionable quality. The solution does not lie in more laws, but in providing more information to the consumer.
- Drug regulators in India have a vast trove of information on substandard drugs which they need to release into a searchable database.
- India has 36 drug regulators, one for each State/Union Territory and the Central regulator. Each of them conducts periodic testing of samples drawn from pharmacies. This testing generates three data sets which need to be publicly available. If this information is made available over the Internet, the government will truly empower hospital procurement officers, pharmacists and patients with information required to avoid products of manufacturers with a poor quality record.
- The government must seriously consider using IT tools to network all 36 drug regulators into one integrated national database. This can then be accessed by every citizen over a smartphone.
Question: Providing accessible and affordable medicines is the foremost priority of a welfare state. But how such concerns should be collaborated along with safety from spurious drugs ?
2.Bhutan’s exit from BBIN (The Hindu, Firstpost)
Synoptic line: It throws light on the challenges posed by Bhutan due to its exit from BBIN. (GS paper II)
- Apart from being a tourist attraction, hot springs are important for various purposes such as energy generation and hosts a lot therapeutic qualities.
- However, in the light of recent findings, hot springs can hold a key to clear a huge environmental menace of oil spills
What is BBIN
- A proposal was made to sign the SAARC MVA during the SAARC Summit in Kathmandu in November 2014.
- Unfortunately, it could not be signed due to reservations of Pakistan. The SAARC declaration at the Kathmandu Summit in November 2014 also encouraged Member States to initiate regional and sub-regional measures to enhance connectivity.
- Accordingly, it was considered appropriate that a sub-regional Motor Vehicle Agreement among Bangladesh, Bhutan, India and Nepal (BBIN) may be pursued.
- The agreement will permit the member states to ply their vehicles in each other’s territory for transportation of cargo and passengers, including third country transport and personal vehicles. Each vehicle would require an electronic permit to enter another country’s territory, and border security arrangement between nations’ borders will also remain
Bhutan leaving the BBIN
- Nearly two years after ministers from Bhutan, Bangladesh, India and Nepal signed the BBIN MVA, the Bhutanese government withdrew the Bill to ratify the pact.
- Right from the time the BBIN MVA was tabled for ratification, the draft legislation faced opposition in Bhutan. Bhutanese suspicion has been that the pact to streamline movement of passenger and cargo transport among the four countries will overwhelm the smallest country in South Asia with traffic, tourists and pollution.
Implications of such a decision
- The BBIN MVA had risen from the ashes of the SAARC version of such an agreement, which fell apart at the 2014 Kathmandu summit after Pakistan objected at the last minute. Hence, for India, the BBIN MVA is of particular significance for its neighbourhood diplomacy. India had been a persistent advocate of the BBIN paradigm partially to demonstrate that an efficient regional pact in the South Asian context could be possible without the presence of Pakistan.
- Moreover, the sub-regional pact was being seen as an important milestone in much touted diplomatic agenda to ‘Look East’ and forge a regional cooperation boosting trade ties in the region.
- Of the other SAARC members, Sri Lanka and the Maldives are not connected by land, and Afghanistan could only be connected if Pakistan was on board. Down to just three countries now after Thimphu’s decision, India, Nepal and Bangladesh will have to decide whether to wait for Bhutan to reconsider or to press ahead with a truncated ‘BIN’ arrangement.
- Connectivity is the new global currency for growth and prosperity as it secures both trade and energy lines for countries en route, and India must make the most of its geographic advantages and should pursue diplomatic channels in a strategic way to bring Bhutan on board.
- India must persevere with its efforts. To begin with, Bhutan’s objections are environmental, not political, and its government may well change its mind as time goes by.
- Bhutan’s concerns may be mitigated if India considers the inclusion of waterways and riverine channels as a less environmentally damaging substitute. Perhaps, Bhutan’s objections may even spur an overhaul of emission standards for trucks currently plying in India, Nepal and Bangladesh.
- India should also focus on BCIM. Although India has refused to attend China’s Belt and Road summit, objecting to projects in Pakistan-occupied Kashmir, the BCIM will remain a way of joining the network when India’s concerns are met.
Question: Though Bhutan’s concerns to opt out from BBIN are legitimate given its advocacy for environment. In such a scenario how India should respond?
3.New Visa rules and its impacts (The Hindu, Times of India)
Synoptic line: It throws light on the repercussions of new protectionist visa regimes which are being imposed by countries. (GS paper II)
- Throughout the world, the wave of protectionism is rising and it is giving rise to a discontent towards foreign professional working in a host country.
- A surge is growing to curtail number of visas given to foreigners for working in high end jobs. Though US is supposed to be forerunner of this movement, but lead has been taken by many countries.
What is H1B visa?
- US has reportedly been looking into reforming the H-1B visa. H-1B visas are for foreign nationals working in “specialty” fields including scientists, engineers or computer programmers, and require higher education.
- The U.S. government awards 65,000 regular H-1B visas every year, which are allocated by lottery and a sizable number of them go to the technology sector.
- Many tech companies in Silicon Valley tend to hire Indians in technical roles either directly or through outsourcing firms such as Indian software company Infosys.
- Critics of the H-1B system have said that the system is set up for companies to exploit and hire low-wage foreign workers in place of Americans.
- A draft legislation, which among other things, calls for more than doubling the minimum salary of H1B visa holders to $130,000. The draft bill aims to make it difficult to replace US employees with foreign workers and experts say it is likely to deal a body blow to companies such as Tata Consultancy Services Ltd (TCS), Infosys Ltd and Wipro Ltd in its present shape.
Movement in other countries
- Rising phenomena of favouring national interests is not only peculiar to US. There are various parallels to such an ideology in various countries.
- The U.K. scrapped a category of short-term visas that have been used extensively by Indian companies to get their IT professionals on-site.
- The Australian equivalent of this is the recent junking of what are called the ‘457 visa’ rules.
- Singapore has reportedly kept approvals for work permits on hold for a while now.
Implications of such a trend
- Due to the changes being proposed, India faces a challenge to its talent-centric, software export model.
- Moreover, if there is a curb on hiring Indian nationals stateside because of reforms to the H-1B program, it could also affect remittances from the U.S.
- World Bank data showed the U.S. was the second largest source of remittance for India in 2015, behind Saudi Arabia, and about $10.96 billion – nearly 16 percent of the total inflows – was sent to India.
- Increased trade protectionism could also hurt Indian exports to the U.S., including pharmaceuticals, textiles, gems and jewellery and auto products.
Question: New visa rules may impact the IT sector of India. What changes India should bring to its domestic policy in this regard?
4.How Bidar beat back the drought (The Hindu)
Synoptic line: It throws light on how by restoring ancient indigenous systems of Bidar’s water life could be (GS paper III)
- Ground water has become the most vulnerable water resources because it has few higher qualities compared to surface water as it is protected from the direct pollution and most importantly the seasonal and perineal fluctuations hardly matter and ground water is much more uniformly spread and conserving ground water is cost effective and reliable and is suitable for any kind of land.
- Hence ground water conservation and recharging has been gaining momentum across world. But this traditional device is today on the verge of destruction and disappearance.
- Karez, the subterranean aqueduct system in Bidar is unique not only by Indian standards, but also globally.
What is karez system?
- One of the most unique features of Bidar is the historic ‘Karez’ system (also known as Qanat) which is a water harnessing technology that originated in Iran/Persia.
- The ‘Karez’ system in Bidar is of great historic significance dating back to almost 500 years. The karez technology basically taps into the ground water sources (or natural springs) and transports it through an underground tunnel to the settlement, ending in surface canal and pools in the village for various uses like drinking, washing, ablution, watering livestock and also further used for irrigating fields, orchards and gardens.
- The structure was unique for three reasons-
- It transfers water from a low-lying watershed to a higher altitude;
- It uses techniques of a reservoir, water duct and a step well;
- Every square inch of the karez is a rainwater harvesting and filtering system as it has been carved out of laterite rock.
- Karez system was built by Bahmani kings in 15th Century by the Bahmani kings in Bidar, Gulbarg and Bijapur in Karnataka and also in Burhanpur in Madhya Pradesh.
- Karez is nothing but the Underground canals, built to underground water streams which are meant to provide drinking water to civilian settlements and garrison inside the Bidar fort.
- This system was necessary in a city like Bidar where the soil was rocky and drilling wells to accommodate drinking water was difficult.
- It is believed that the Muslim rulers of Bidar, under the expert advice of Persian engineers followed Karez system by laying subterranean canals in the heart of the rock by widening the natural rift.
- The Naubad Karez is estimated to have been constructed during the Bahmani Period (1347 – 1518 AD). The Karez was probably directed towards developing infrastructure for a village at Naubad.
Importance for Bidar
- Bidar is semi-arid region that receives 60-100 cm of rainfall annually. Its terrain is uniquely composed of ‘duricrust’ honeycomb-structured laterite (hard but porous and capable of absorbing rain water when forested with the right vegetation), below which lies the impermeable basalt of the Deccan trap that does not allow what is collected to percolate away.
- Following the overall deficit rainfall since 2012, most of Bidar’s bawdis and kalyanis (open wells and tanks respectively) ran dry. When this happened, people took the karez and bawdis seriously and it was easier to generate awareness about them. In a way, the crisis became an opportunity.
- Being a drought prone area, restoration of karez system is definitely very much importance of livelihood.
- Bidar YUVAA (Youth United for Vigilance, Awareness and Action) is carry forwarding Kerala-based geologist and Professor Govindan Kutty’s work on the ground, engaging on local authorities to undertake the de-silting and cleaning of wells as part of MGNREGA projects; litigating against the encroachment of watershed land; protesting the proliferation of indiscriminately deeper tube wells that have caused the water table to drop drastically, adversely impacting the karez’s mathematical reliance on gradients; planting over one lakh indigenous trees so that rainwater wouldn’t run off before it could be absorbed; and creating awareness to prevent the dumping of garbage, and open defecation, along the karez.
- One of biggest challenges in the restoration of Karez is 1.5-km-long Kamthana embankment to the south-west of the city, which falls on the old route between Bidar and Gulbarga, the breached embankment is seen with its moat in ruins, the adjoining forested areas barren, and the tank to which its water channels lead in shambles.
- Another challenge is a ring road proposed by the Bidar Urban Development Authority’s Master Plan, which connects to the Naubad-Hyderabad highway and bypasses Bidar town, bifurcates the second of two agricultural zones that used to be fed by the karez, endangering the system.
- Rapid urban development is causing the unique laterite plateau to erode. Railway line cuts through the catchment area of the Naubad embankment, which lies directly above geologic fractures or water movement channels called lineaments.
- However, state is restoring karez efficiently, The Department of Tourism is funding some of restoration work, and Karnataka Urban Infrastructure Development Finance Corporation has also identified the conservation of the Naubad karezsystem as one of 17 projects shortlisted for a pilot study.
- The awareness programme with karez system importance will be very helpful, involvement of NGOs, local leaders will also expedite the restoration activity. Moreover, a cue should be taken and more environmentally sustainable indigenous methods should be adopted at local levels. They will be even cheaper substitutes and they will provide boost to local expertise and know how as well.
Question: Water scarcity will nothing but increase in the days to come. What indigenous methods and traditional wisdom can be employed to fight water scarcity?