Thursday, October 3, 2024
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Urgent need for quality assurance in India’s pharmaceutical sector

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Editor,
The recent findings from a comprehensive report by the Central Drugs Standard Control Organisation (CDSCO), India’s leading drug regulatory authority, have raised significant concerns about the quality control processes for numerous pharmaceuticals commonly used in the country. These issues could have serious implications for public health and the overall credibility of India’s pharmaceutical sector, which is globally recognised for its extensive production of generic medications.
The CDSCO report lists over 50 pharmaceutical products that do not meet the required quality standards. This list includes medications like “Paracetamol,” which is widely used by many as an over-the-counter drug/medicine. Other drugs include antibiotics, drugs relating to treatments for chronic conditions such as diabetes and hypertension, as well as essential supplements like vitamins and calcium. Key issues identified include poor manufacturing practices, inadequate quality control, and contamination, all contributing to the shortcomings. A major concern highlighted was the inconsistency in the levels of APIs (Active Pharmaceutical Ingredient) in these products, which are vital for ensuring a drug’s effectiveness and safety.
These substandard medications pose a significant risk to patient safety. Products with inadequate or inconsistent APIs may fail to effectively manage medical conditions, potentially leading to prolonged illnesses and serious complications. Moreover, these drugs could cause adverse effects, including allergic reactions and, with prolonged use, potential harm to vital organs like the liver and kidneys. This is especially alarming because these medications are meant to treat conditions that demand precise and reliable treatment.
In a comprehensive evaluation of manufacturing standards, the CDSCO inspected 400 manufacturing facilities and found that 36% did not comply with existing regulatory requirements, resulting in their closure. This finding points to systemic issues within parts of the pharmaceutical production chain that threaten drug safety and effectiveness. However, pharmaceutical companies have denied these allegations, claiming that the problems arise from counterfeit products entering the market. Despite their clarifications, previous reports suggest that issues persist.
India is globally known as the “world’s pharmacy,” producing about 20% of the world’s generic drugs. Maintaining this status is vital not only for its economy valued at over $60 billion in 2023, but also for global healthcare systems that depend on its medicines. If these quality issues are not addressed promptly, India’s reputation for providing affordable and reliable medications could suffer, with far-reaching consequences.
To tackle these challenges, a multi-faceted approach is essential. First, regulatory bodies must implement rigorous inspections and compliance standards by improving oversight and strictly enforcing manufacturing protocols. There should also be a focus on advanced quality management systems to ensure consistent production. Public education campaigns are crucial to raising consumer awareness, encouraging people to verify the authenticity of medications, possibly through certifications from reputable organisations like ISO or WHO.
The CDSCO’s findings serve as an urgent call to action to protect public health and uphold the reputation of India’s pharmaceutical industry. While regulatory reforms are essential for long-term improvements, consumers’ vigilance and informed choices are equally important in addressing immediate risks. Collaborative efforts among regulatory bodies, manufacturers, and healthcare providers will be critical in restoring confidence in Indian-made pharmaceuticals on a global scale.
Yours etc.,
Chanmiki Laloo
Shillong-02

Larger issues of animal slaughter

Editor
The conflict between those who eat beef — and Hindus (like Swami Avimukteshwarananda Saraswati) who want to ban beef in India — because they regard the cow as mother — is filled with thorny ethical dilemmas. At face value, it sounds noble to show gratitude to the cow, for giving us milk — quite as we thank the mother who sacrifices her body to nourish her child. To produce milk, the cow has to be pregnant constantly, which is why animal rights activists prefer plant-based milk substitutes here in America.
Mine is an animal rights perspective. If all domestic animals went on strike for a week, the human world would collapse. We depend on animals, not just for food, but for unrewarding labour and companionship. With human relations failing, mankind is turning increasingly to pets.
But the greatest sacrifice of birds, fish, and animals lies in their unwilling, often tortured deaths for the sake of the human palate. Yet living entails taking life. For some, meat is not a luxury, but a health-based necessity. The point, therefore, should be to honour all birds, fish, and animals who are forced to sacrifice their lives for us — not just the cow. Moreover, when we have to take life, we should do so in ways that minimize pain. From a pain-centred perspective, butchering practices need to become more humane than they are at present. There is no excuse for the needless cruelties of factory farming, or for using animals for luxury purposes, as in the fur industry. Inasmuch as animals are sentient beings who feel pain, we should make every effort to minimize their pain. We should also thank them for their sacrifices, as did the Native Americans in America.
The cow has become a focal point of ideological Hinduism, which distorts the teachings of higher Hinduism. I can imagine the pain of those who sincerely love animals and the cow, when confronted with modern butchering practices and meat eating. But when the cow is singled out in volatile ideological ways, cow worship becomes a Pandora’s Box filled with self-projection and narcissism — not real concern or love for the cow and other living beings.
Yours, etc.,
Deepa Majumdar,
Via email

Request for revision of Meghalaya State Reservation Policy

Editor,
I am writing to bring to attention a critical issue regarding the state reservation policy, particularly in light of the recent advertisement by the Meghalaya Public Service Commission (MPSC), via Office Order No. MPSC/ADVT-54/1/2024-2025/1. The roster system in place follows the state’s reservation policy, where posts are categorized as Unreserved (UR), Khasi-Jaintia (KJ), and Garo. However, there appears to be a glaring issue regarding the inclusion of the Economically Weaker Section (EWS) and Other Backward Classes (OBC) in this policy.
It has been observed that UR posts are often filled by candidates from the Scheduled Tribes (ST), while other sections, such as those under the EWS category, are left unaccounted for in the reservation roster. This raises the question—why has the EWS category, which has been officially recognized by the Government of Meghalaya, not been incorporated into the state’s roster policy? The lack of provision for this category limits opportunities for individuals who fall under EWS, further complicating an already complex reservation system.
Furthermore, there is a conspicuous absence of OBC representation, particularly in Shillong, where obtaining an OBC certificate is reportedly difficult. It is unclear why the OBC category has been scrapped, but it is undeniable that this decision affects a significant portion of the state’s population, denying them access to benefits they are entitled to.
This exclusion not only raises concerns about fairness and inclusivity but also about the overall development of the state. As citizens of Meghalaya, we seek a reservation system that addresses the needs and welfare of all communities—whether tribal, economically weaker, or otherwise marginalized. The current policy appears to neglect this objective, which could lead to a further divide among the populace.
I urge the authorities to take this matter seriously and revise the existing reservation policy to ensure that it is inclusive of all citizens. Addressing these gaps is essential to promote equal opportunities and foster the growth and development of Meghalaya as a whole.
Yours etc.,
Name withheld on request,
Via email

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