Drugs and Cosmetic Rules, 1945
For prelims and mains: Generic drugs- significance, concerns, usage and efforts by the government to promote them.
Context: The Central Government is considering amendments to the Drugs and Cosmetic Rules, 1945 to ensure that registered medical practitioners dispense only generic medicines.
Background:
A proposal was recently received by the Central Drugs Standard Control Organisation (CDSCO) committee wherein the Drugs Consultative Committee (DCC) was apprised that registered medical practitioners can supply different categories of medicines including vaccines to their patients under the exemption provided, with certain conditions, under Schedule K of the Drugs and Cosmetics Rules, 1945. As of now there are no specified types of medicines which can be supplied by doctors to their patients.
It is now proposed that registered medical practitioners shall supply generic medicines only and physicians samples shall be supplied free of cost.
What is a Generic Medicine?
Generic medicines are unbranded medicines which are equally safe and having the same efficacy as that of branded medicines in terms of their therapeutic value. The prices of generic medicines are much cheaper than their branded equivalent.
Why are they cheaper?
Since the manufacture of these generic drugs do not involve a repeat of the extensive clinical trials to prove their safety and efficacy, it costs less to develop them. Generic drugs are, therefore, cheaper.
However, because the compounds in the generic versions have the same molecular structure as the brand-name version, their quality is essentially the same.
Why aren’t generic drugs more popular?
- Lack of awareness about them.
- Since they are cheap, people who can afford branded drugs don’t buy them believing them to be of inferior quality. Chemists have to hand out exactly what’s written on the prescription and most doctors except in government hospitals don’t hand out generic drugs.
- Also, private doctors never hand out generic drugs because there are no kickbacks or incentives involved from pharma companies.
- The government or specifically the government’s Department of Pharmaceuticals is also to blame for the lack of awareness.
However, there are three fundamental areas of concern:
- Efficacy of Indian-made drugs: Oftentimes, such drugs have been found to contain less than the required amount of active pharmaceutical ingredient (API), rendering them ineffective.
- Lack of data integrity: The poorly managed documentation practices of Indian generic firms featured as the primary criticism flagged by foreign regulatory authorities. The lack of reliable and complete data on the test results of specific drug batches, along with inconsistencies in the records presented, meant that inspection and verification of drug quality was extremely difficult.
- Hygiene standards of the manufacturing plants: Individuals suffering from illness are especially susceptible to infections, and inspections of generic drug plants reveal pest infestations and dilapidated infrastructure.
Various efforts by the government:
‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ is a campaign launched by the Department of Pharmaceuticals, Govt. Of India, to provide quality medicines at affordable prices to the masses through special kendra’s known as Pradhan Mantri Bhartiya Jan Aushadhi Kendra.
Bureau of Pharma PSUs of India (BPPI) is the implementing agency of PMBJP. BPPI (Bureau of Pharma Public Sector Undertakings of India) has been established under the Department of Pharmaceuticals, Govt. of India, with the support of all the CPSUs.
UNESCO World Heritage Sites
For Prelims: UNESCO WHS- important sites.
For Mains: Significance and the need for conservation of WHS.
Context: India gets its 38th UNESCO World HERITAGE SITE as Pink City Jaipur.
With Successful inscription of Jaipur City, India has 38 world heritage sites, that include 30 Cultural properties, 7 Natural properties and 1 mixed site.
UNESCO world heritage site:
- A UNESCO World Heritage Site is a place that is listed by the United Nations Educational, Scientific and Cultural Organization (UNESCO) as of special cultural or physical significance.
- The list is maintained by the international World Heritage Programme administered by the UNESCO World Heritage Committee, composed of 21 UNESCO member states which are elected by the General Assembly.
- Each World Heritage Site remains part of the legal territory of the state wherein the site is located and UNESCO considers it in the interest of the international community to preserve each site.
Selection of a site:
To be selected, a World Heritage Site must be an already classified landmark, unique in some respect as a geographically and historically identifiable place having special cultural or physical significance (such as an ancient ruin or historical structure, building, city, complex, desert, forest, island, lake, monument, mountain, or wilderness area). It may signify a remarkable accomplishment of humanity, and serve as evidence of our intellectual history on the planet.
Legal status of designated sites:
UNESCO designation as a World Heritage Site provides prima facie evidence that such culturally sensitive sites are legally protected pursuant to the Law of War, under the Geneva Convention, its articles, protocols and customs, together with other treaties including the Hague Convention for the Protection of Cultural Property in the Event of Armed Conflict and international law.
What are endangered sites?
A site may be added to the List of World Heritage in Danger if there are conditions that threaten the characteristics for which the landmark or area was inscribed on the World Heritage List. Such problems may involve armed conflict and war, natural disasters, pollution, poaching, or uncontrolled urbanization or human development.
This danger list is intended to increase international awareness of the threats and to encourage counteractive measures.
Review: The state of conservation for each site on the danger list is reviewed on a yearly basis, after which the committee may request additional measures, delete the property from the list if the threats have ceased or consider deletion from both the List of World Heritage in Danger and the World Heritage List.
Indo-Afghan trade chokes on U.S. curbs
ForPrelims and mains GS III Indian Economy, GS II International relations
In news
- The government’s decision to slash its allocation for Iran’s Chabahar port by two-thirds will be a further blow to India-Afghan trade, already hit by Pakistan’s decision to ban airspace rights to most flights to and from India, and U.S. sanctions on Iran.
- The government, which had been allocating ₹150 crore for the port each year for the past few years, has slashed its allocation to just ₹45 crore in the Budget for 2019-20.
Waiver of little help
- Technically, the U.S. has issued India a waiver to develop the Chabahar port, to promote trade with Afghanistan as part of its “South Asia” strategy.
- In practice, however, the cancellation of all waivers for oil and crippling economic sanctions imposed by the Trump administration, have all but frozen deals.
- Afghan banks are hesitant to open credit lines for shipments, and shippers and cargo handlers are staying away from servicing the Iranian port.
- As a result of Pakistan’s airspace ban, Afghan fruit and agricultural products that had made up a bulk of the cargo on flights between Kabul and Delhi are being shipped to other international markets.
Gandhian Young Technological Innovation (GYTI) Awards:
SRISTI (Society for Research and Initiatives for Sustainable Technologies and Institutions) celebrates the creativity and innovation of young technological students by recognising their outstanding projects with Gandhian Young Technological Innovation (GYTI) Awards.
These Awards celebrate the spirit of student innovation in all the fields of engineering, science, technology and design through extremely affordable/frugal solution or the ones pushing the technological edge.
Bucks for the banks: Union Budget
Introduction :
The 2019-20 budget has many interesting features, but it does not have a defining central theme. There were expectations of a big growth push through either tax cuts or large expenditure programmes even if it meant a rise in the fiscal deficit. But the Finance Minister has chosen to be fiscally conservative, opting to play the long-term game, though it could lead to pain in the short term.
Banking sector and NBFCs
- Budget provided for ₹70,000 crore capital infusion in banks. It is hoped that it will spur lending to growth sectors in the economy.
- It has comprehensively addressed the important issues of liquidity, solvency and poor governance in the NBFC sector.
- A liquidity window of ₹1 lakh crore has been made available to public sector banks through the Reserve Bank of India to buy pooled assets of NBFCs and offered a one-time credit guarantee for first loss of up to 10%.
- To enable better supervision of the sector, housing finance companies will come under the RBI’s regulatory ambit.
- A long-standing demand of NBFCs for equitable treatment with banks in the matter of taxing interest receivable on bad loans has been conceded.
- They will not need to maintain a Debenture Redemption Reserve on public placements that was leading to locking-up of funds, which is their raw material for business.
- The big problem faced by NBFC financing infrastructure is the lack of long-term funding sources to match their lending tenure.
- This pushed them into borrowing short-term funds to lend to long-term projects, leading to asset-liability mismatches.
- The proposal to set up a committee to study the issue, including the experience with development finance institutions, is welcome.
Debenture Redemption Reserve
A debenture redemption reserve (DRR) is a provision stating that any Indian corporation that issues debentures must create a debenture redemption service in an effort to protect investors from the possibility of a company defaulting.
Strategic disinvestment
The government reiterated its commitment to strategic disinvestment and the declared that it is willing to allow its stake to fall below 51% in non-financial PSUs.
Aadhaar and PAN
- The government seems to be moving towards a single identity card for citizens in the form of Aadhaar, which will now be interchangeable with the PAN card.
- Taxpayers who do not have a PAN card can file returns quoting their Aadhaar number, which effectively can be a substitute for PAN in all transactions.
Faceless e-assessment of tax returns
- Another reform measure is the introduction of faceless e-assessment of tax returns taken up for scrutiny.
- This will eliminate the scope for rent-seeking by officers as there will be no interface between assessee and official.
- In fact, the assessee will not even know the identity of the officer scrutinising the return.
- This is an absolutely welcome measure but needs to be closely watched for implementation.
Start-ups and corporate sector
- Start-ups can heave a sigh of relief as the angel tax is practically off the table.
- The corporate sector has got a minor sop with the turnover limit for the 25% tax bracket being raised to ₹400 crore per annum from ₹250 crore.
- The expectation was that this would be extended to all companies irrespective of size.
- It appears that the government wants to wait for the finalisation of the Direct Taxes Code, which is being examined by a committee.
Real estate sector
- Real estate companies may have reason to cheer as the generous tax concession for affordable housing may create demand, especially in the smaller metros.
Nudge theory
The ‘nudge theory’ of economist Richard Thaler, mentioned extensively in the Economic Survey 2018-19, has been put to use to push forward two of this government’s pet themes — increasing digitalisation of money and promoting electric mobility.
Nudging for digitalization
- On the first, there will now be a 2% tax deducted at source when withdrawals from bank accounts exceed ₹1 crore in a year.
- This is a commendable measure, but it could lead to genuine problems for businesses such as construction and real estate that are forced to deal in cash for wage payments.
Nudging towards electric vehicles
- Here those taking loans to buy one will get a tax deduction of up to ₹1.5 lakh on the interest paid by them.
- But the fact is that there are not too many electric vehicles in the market now. And even for those that are there, the waiting period to deliver one is long.
- Besides, there is no ecosystem, such as charging points, even in the major cities. The government’s hope seems to be that this incentive will create a market for e-vehicles that will then lead to the development of the ecosystem.
Fiscal deficit
- The budget documents show that the government has stuck to the glide path for fiscal deficit, which will be at 3.3% this fiscal. This is, however, based on exaggerated growth projections in tax revenues.
- It will be possible with a comfortable buffer if the Bimal Jalan committee that is going into the sharing of RBI’s reserves with the government comes up with favourable recommendations.
- The government also appears to be sliding into a protectionist mode, going by the increase in customs duty on many things.