For the last few months, big questions are being raised regarding the quality of medicines made in India. In such a situation, it is estimated that the state drug regulatory bodies can be reformed through the Central Drug Regulatory. Kavita Pant is telling in detail.
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India has earned the title of pharmacy of the world for reliable medicines. Due to all the medicines made in the country, developed countries also helped in reducing the cost of healthcare. But recently due to some incidents this image has suffered a major setback and questions are being raised on the quality of Indian medicines.
Talking about recent incidents, eye drops manufactured by an Indian pharmaceutical company are believed to be responsible for the loss of eyesight of some people in America. And last year Made in India cough syrup has been linked to the death of some children in Gambia and Uzbekistan.
What is the matter?
Regarding the questions being raised about the quality of India-made drugs in the last few months, Dr. Krishna Ella, Executive Chairman of Bharat Biotech, believes that all the state-level drug regulatory bodies should be linked with the Central Drugs Standard Control Organization (CDSCO). Should be taxed so that uniform standards can be established for Indian medicines.
Dr. Ella says that it is very important to centralize the system of Indian medicines because the cough syrups in question were not approved by the central body but by the state regulatory body. According to Dr. Ella – We have companies making excellent medicines here, but due to some local agencies, questions are being raised on our industry.
Growth in the pharmaceutical sector
Statistics show that the Indian pharmaceutical industry has registered a spectacular growth in the last few decades, which is about 1.72% of the country’s total GDP. Presently the Indian pharmaceutical industry stands at a figure of $50 billion. At the same time, in the Economic Survey 2022-23 presented in the Parliament, this industry has been estimated to reach up to $ 65 billion by the year 2024 and $ 130 billion by 2030.
Due to the increasing demand for cheap and high quality medicines domestically and internationally, there has been a huge growth in this sector. India’s pharmaceutical industry offers over 60,000 generic brands across 60 therapeutic categories. In this way the country has earned the title of ‘Pharmacy of the World’ by supplying 20 percent of the world’s generic drug exports.
understand the matter a little more
However, some countries have expressed concern over the quality and safety of medicines manufactured in India. In fact, in recent years, medicines made by some Indian pharmaceutical companies have not been found to conform to the standards of Good Manufacturing Practices (GMP), due to which questions are being raised about their quality and being safe for patients.
In such a situation, it is estimated that the quality of drugs manufactured in India can be improved by bringing the state drug regulatory bodies under a central drug regulatory body. By centralizing the regulatory system, a uniform standard of drug making can be set, which is currently being looked after by various state bodies. Because of this, a single standard of medicines is not fixed across the country.
According to Dr. Ella’s suggestion, creating a central level system would make it easier to regulate the pharmaceutical industry and thus lead to better quality control. This system can help in improving the overall quality and safety of Made in India medicines.
However, it is also worth noting that merely creating a central system to regulate state level agencies cannot be a guarantee of quality improvement. Along with this, it will also have to be ensured that this central body has full resources, expertise and enforcement powers to test and maintain the quality of drugs.
Why is the issue important?
Many Indian pharmaceutical companies have a good reputation for making high-quality effective drugs and have stringent quality control regulations. The Government of India has also taken necessary steps to strengthen its regulatory system so that the quality of drugs manufactured in the country and exported from here can be ensured.
But the reason for the making of sub-standard drugs in India can be attributed to the absence of inadequate regulations and inspection system. A report by The Central Drug Standard Control Organization of India – the official regulatory body that monitors drug quality, states that about 4.5 percent of drugs in the Indian market are of substandard quality. A World Health Organization survey also found that 10 percent of the drugs exported from India to low- and middle-income countries were substandard.
To maintain the country’s credible image as a drug supplier, India needs to take effective measures against substandard manufacturers and for this it needs to improve its regulatory system. By giving quality control of medicines in the hands of the states, corruption can increase in this system and then due to bureaucracy and various inefficiencies, there will be difficulty in taking effective action on them.
On drugs, Akhil Ramesh, a researcher at the Pacific Forum, a foreign policy research institute based in Honolulu, Hawaii, says that in such a situation some states, especially export-oriented manufacturers, compromise consumer safety to serve their business interests. can do.
Nikkei Asia In his conversation with, Ramesh said that India should regulate the pharmaceutical industry at the national level and keep a close watch on those who repeatedly violate the rules. And if a company does not stop violating the safety guidelines, then its license should be canceled with immediate effect.
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