फिक्स्ड डोज़ संयोजन (एफडीसी) दवाएँ क्या हैं? भारतीय बाजारों में असुरक्षित एफडीसी दवाओं के प्रसार के कारकों पर चर्चा करें।
Suggested Answer:
When two or more drugs are combined in a fixed ratio into a single dosage form, it is termed as fixed dose combinations (FDCs). They were conceptualized on the idea that certain drugs potentiate the action of other drugs when given together. FDCs are popular due to the many advantages they provide, like-
- Reducing the incidence of adverse effect of drugs
- Reducing the pill burden
- Reducing dosage of individual drugs
- Decreasing development of resistance
- FDCs are cheaper than individual drug because of reduced cost from packaging to distribution.
India has become the world’s leading market for FDCs with an estimated 6000 FDCs being issued to patients. As per the Rule 122E of Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs and the Central Drugs Standard Control Organization (CDSCO), after due examination of data on rationality, safety, and efficacy, issues approval. On the basis on this, the State Licensing Authority (SLA) gives the manufacturing and marketing permission. However, there is a wide prevalence of unapproved FDCs in India due to reasons like-
- Economic factors-
- o Commercial interests and high profit motives of the manufacturing pharma companies is a prime reason behind prevalence of unsafe fixed dose combinations
- o Due to the difficulties in developing new chemical entities, the pharmaceutical industry finds it easier to develop FDCs.
- o Earlier, drug companies used to reformulate some drugs into FDCs so as to evade the price control put on these drugs, which were included in Drug Price Control orders. This loophole has been plugged recently.
- o There is a high demand for low-cost medicines, which is being capitalized by manufacturers by issuing sub-standard and unapproved medicines.
- Administrative and governance factors-
- o Nexus between doctors and manufacturing companies with mutual profit motives has resulted in promotion of unsafe FDCs
- o Lack of control mechanisms to prevent the use and sale of unsafe/unapproved drugs.
- o State Licensing Authorities have issued licenses without checking for clearances with either Central Drugs Standard Control Organization or Drugs Controller General of India.
- o Corruption is the major cause for many lapses by the entire administrative setup.
- Judicial factors-
Many positive steps, like banning of certain FDCs and revoking their licenses, have been reversed by the courts (although the executive was also at fault for not following proper procedures). Many manufacturers have filed petitions in courts challenging the regulatory powers of CDSCO to ban FDCs.
- Role of Marketing and leaders-
The strong marketing pressure, inadequate time and attitude of critical analysis, influences the prescribing habit toward these FDCs. Senior leaders in medicine from academia and practice who are key opinion leaders influence the prescribing trend of their juniors and have a cascading effect on the medical community.
To curb the irrational use of FDC in India, a multistep approach involving all stakeholders, for example, consumers, physicians, regulatory authority, industry, and the academicians, is needed. But above all, there is a need to change the social mindset of the patients to make them more aware of the pros and cons of FDCs
संवैधानिक और कानूनी प्रावधानों के प्रकाश में, सुप्रीम कोर्ट का कितनी दूर तक यह फैसला करना की सिनेमा हॉल में राष्ट्रगान अनिवार्य है, जायज़ है? क्या यह आम जनता में देशभक्ति पैदा करने में सहायक हो सक्ता हैं?
Suggested Answer:
Recently, the Supreme Court made playing of national anthem with display of national flag in cinema halls compulsory. It was also ruled that all the persons present need to stand (to show respect) and that the doors need to be temporarily closed (not locked) to prevent people from entering or leaving while the anthem was being played. This ruling has justifications, like-
- The court justified the ruling by stating that not only is it one’s duty to respect the national anthem but also it instills feeling of patriotism.
- Art 51A of the Constitution says that it is the duty of every citizen to abide by the Constitution and respect its ideals and institutions, the national flag and the national anthem.
- Showing respect to national symbols builds unity among people.
However, these justifications have valid counter arguments-
- Art 51A is under Fundamental Duties which are not justiciable in courts.
- There is absolutely no proof of the statement that paying respect to national symbols instills patriotism.
- The order not only impinges on individual rights but can also be seen as a judicial over reach.
- The Parliament has enacted The Prevention of Insult to National Honours Act, 1971, which doesn’t make it mandatory to sing the national anthem.
- It will be difficult to implement such an order (with the police already suffering from understaffing).
- It might lead to instances of vigilantism and mob justice.
- Cinema halls are being singled out (for acting as a place to show patriotism) as no such order applies to other similar public places like drama theatres or other cultural displays.
Based on above reasons, it can be seen that not only is the ruling shortsighted but also that it might not lead to instilling patriotism in citizens. Patriotism cannot be forced on someone. Patriotism is a value that most people cherish without being required to demonstrate it in visible ways. Unfortunately, a notion has emerged in the country that it ought to be articulated frequently and demonstrated publicly. What one needs is not legislations and judicial rulings for spreading patriotism but more tolerance and acceptance for individual rights and beliefs.
ग्रामीण भारत के विशेष संदर्भ में डिजिटल भुगतान प्रणाली के समस्याओं को लिखें। क्या भुगतान प्रणाली के डिजिटलीकरण होने द्वारा काले धन की समस्या से निपटा जा सकता है?
Suggested Answer:
Indian economy is undergoing an unprecedented digital transformation following the demonetization initiative. Along with benefits like formalization of economy, checking corruption & black money generation, widening tax-base, reducing fiscal deficits, digital payment systems also create numerous challenges like data security, fraud, hidden charges etc. Such challenges are acute when it comes to rural India.
Challenges faced by Rural India-
- Lack of basic infrastructure like power supply, phone and internet connectivity etc hinder the usage of digital payment systems. Internet connectivity remains low among the isolated, remote rural hinterland. National Optical Fiber Network under BharatNet project could only connect 8000 out of 2.5lakh panchayats till date.
- Penetration of smart phones and banking services is low. Not every citizen has a bank account to link to their mobile device/card. And not every shop/merchant accepts non cash payments.
- Low digital literacy and behaviour patterns like habit of using cash, fear of the unknown, resistance to change etc. The economy is largely informal and is highly dependent on cash. It is also difficult to teach the usage of any new method especially if it is complex.
- One of the biggest challenges is the concern over security of payment methods. People fear that the devices can be hacked, their money will be stolen, their data can be cloned and misused etc. They hesitate in disclosing their account details. They are also vulnerable to identity theft and other financial frauds.
- Other issues like charges levied on transactions, lack of availability of card payment options etc also act as a hindrance in usage of digital options.
Despite these challenges, digital payment systems do offer significant advantages. The biggest of them is that they act as a check on black money generation since every transaction happens within the economy’s formal financial system. Also, transactions leave a paper trail which can be tracked during investigations. However, digital payments alone might not be able to stop black money generation, as-
- A major component of black money is held in immovable assets like real estate properties and gold/jewelry.
- Corporate practices like Base erosion, Transfer pricing and loop holes in DTAAs lead to persistent tax evasion.
- Cash transactions will never be completely eliminated.
Move towards digitization is a positive step. However, there are still a lot of challenges to be faced and overcoming these challenges is necessary for providing its benefits to all.
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