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The article published in the editorial section of The Hindu Newspaper highlights the failure of India’s drug regulation system to effectively address three key issues: removing unsafe drugs from the market, ensuring proper storage of drugs, and preventing confusing drug names. These problems have been known for decades, but because of weak laws and constant delays in decision-making, they continue to pose a risk to public health. The article suggests that without strong leadership or direct intervention from higher authorities, such as the Prime Minister’s Office, these problems are unlikely to be resolved anytime soon.
1. Drug Recall Guidelines:
The recall guidelines are meant to help remove unsafe or faulty drugs from the market. These are drugs that have failed quality tests in government labs, meaning they could be harmful to people. The idea behind recall guidelines is simple: if a drug is found to be dangerous, it should be quickly pulled off the shelves.
However, there’s a big problem. These recall guidelines aren’t backed by strong legal power. This means that if a company doesn’t follow the guidelines, there are no real consequences, and the faulty drugs may continue to be sold. Although this issue has been discussed since the 1970s, the government has not been able to create laws that make these guidelines mandatory. This results in a situation where even if unsafe drugs are identified, there’s no proper system to ensure they are removed from the market.
2. Good Storage and Distribution Practices:
The second issue deals with how drugs are stored and transported. In a country like India, where the weather can be very hot and humid, it’s crucial that medicines are stored at the right temperature. If not, the drugs can degrade, meaning they might lose their effectiveness or even become harmful. Good distribution practices (GDP) are guidelines that make sure drugs are stored properly from the time they are made to when they reach the pharmacy or hospital.
Despite the importance of this, these guidelines are not legally required either. There was an effort to make these guidelines mandatory, but it faced opposition. Many small pharmacies didn’t want to spend money on the necessary storage equipment, so the proposal was rejected. As a result, many drugs in India are still stored improperly, which is risky for people who rely on them for their health.
3. Confusing Drug Brand Names:
The third issue is about the confusing names of drugs. In India, many medicines have similar brand names, which can easily confuse doctors, pharmacists, and patients. For example, if two drugs sound alike, a pharmacist might give the wrong one by mistake. This can be dangerous, especially if the drugs have different effects.
To fix this, the government could check drug names before they are allowed to be sold, making sure no two drugs have names that are too similar. But instead of doing this, the government asks drug companies to declare on their own that their brand name is unique. This system doesn’t work well because it leaves the responsibility to the companies, and many confusing drug names still exist. Other countries have stricter rules where the government checks and approves drug names to prevent confusion, but in India, this is not happening effectively.
Long-Standing Issues:
These problems are not new. The lack of proper drug recall guidelines, poor storage practices, and confusing drug names have been concerns for decades. In 2012, a Parliamentary Standing Committee pointed out these issues in a detailed report. Even before that, in the 1970s and 1980s, the courts and drug authorities raised concerns. Despite all this, the Ministry of Health hasn’t been able to make these guidelines legally binding or implement strong reforms.
For example, the idea of drug recall guidelines was first discussed in 1976, yet even today, India doesn’t have proper laws to enforce them. Similarly, the issue of proper drug storage was highlighted by the Supreme Court in 1974, and the problem of confusing drug names was flagged by the courts in 2001. Even with all this attention, no effective actions have been taken.
Bureaucratic Delays:
One of the reasons for this lack of progress is that the drug regulation system in India is slow and filled with delays. The article explains that the Ministry of Health, which is responsible for making laws and enforcing these guidelines, often gets stuck in a loop of consultations and discussions.
Each time a new official is appointed to handle drug regulation, they have to consult with various stakeholders, such as pharmaceutical companies and trade associations. These groups often resist changes because they may not want to spend more money or make adjustments to their practices. As a result, real reforms are continuously postponed.
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The Hindu Epaper Editorial Explanation given by Hello Student is only a supplementary reading to the original article to make things easier for the students.
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The Editorial Page of The Hindu is an essential reading for all the students aspiring for UPSC, SSC, PCS, Judiciary etc or any other competitive government exams.
This may also be useful for exams like CUET UG and CUET PG, GATE, GMAT, GRE AND CAT
To read this article in Hindi –https://bhaarat.hellostudent.co.in/