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Medical practitioners across the country have warned of grave side effects of counterfeit and substandard drugs that can impact on human beings, and have raised concerns about the present situation of the Indian drug market, especially in West Bengal.
Urging caution, the physicians highlight the risks that can affect the health of the people if the duplicates of medications, which are marketed along with genuine drugs, are consumed. The doctors want the central and state regulators to be vigilant and urge them to initiate stringent measures to weed out fake medications from the Indian drug market.
According to them, the counterfeit medicines are not only inefficacious to cure a disease, but they cause hazardous side effects and permanent harm to organs.
According to Prof. Dr. Mukesh Yadav, ex-president of Indian Association of Forensic Medicine (IAFM) and present principal of government medical college in Lucknow in UP, the origin, active ingredients and effectiveness of counterfeit medicines are not known, and they are hazardous to human body. One cannot ensure its quality and side effects they can have on the human body due to lack of information or incorrect information. Not only patient safety is at stake, but regulatory violation and reputation of all stakeholders are also at stake.
Talking to Pharmabiz over phone from Lucknow, Dr. Yadav said, depending on clinical profile of patient, disease, age, etc, the counterfeit and substandard medicines may affect many vital organs of the human body. They may be life threatening in some cases.
As regards ways to control their entry into the market, he said, there is an urgent need to check the sale and distribution of these fake medicines. Actually, it affects the ‘right to live’ under Article 21 of the Indian Constitution. So, regulatory bodies should come forward to play their proactive role to control the sale and distribution of these fake drugs.
Dr V Kanagasabhai, former principal and dean of Madras Medical College, and Ex-DME of Tamil Nadu, says that counterfeit medicines can create serious problems based on the medical condition of the patients. “Anything from mild allergy to organ damage may occur, especially if taken for long. Further, the desired result will not be obtained from such duplicate medications which do not contain the same quality and quantity of the active chemical ingredients. Moreover, it contains other chemicals which will reduce the absorption, or interfere with the metabolism of the active drug molecules.”
He commented that strict punishment should be served to those who market such medicines, so that it will deter others from doing such illegal and unethical business. According to Dr Kanagasabhai, the drug regulatory bodies should be strong to prevent the entry of counterfeit medicines into the market.
Dr Sumol Ratna, Assistant Professor at the Department of Medicine at the NIIMS Medical College and Hospital in Greater Noida in UP says that the counterfeit medicines can create a lot of reactions in patients. The most common reactions include allergies, organ damage, gastrointestinal issues, dizziness and in some cases seizure or cardiac arrest may happen. She said counterfeit contributes to the rise of drug-resistant diseases in human beings and often increases the mortality rate.
When asked what are the lifestyle diseases that can become more hazardous if counterfeit drugs are consumed, Dr Sumol Retna said lifestyle diseases like diabetes, hypertension, cardiovascular diseases and respiratory disorders can become more dangerous if counterfeits are consumed. Ineffective medicines can lead to uncontrolled blood sugar, high blood pressure, heart attacks, strokes and respiratory failures putting a person's health at risk.
Dr M Murali Bhaskar, a telemedicine practitioner in Hyderabad is of the opinion that the counterfeit medicines lack the required active pharmaceutical ingredients. Most of them contain only fillers or placebos. Even when active ingredients are present, they may be degraded due to improper storage or handling during manufacturing and distribution processes. Many counterfeits contain sub-therapeutic dosing with insufficient amounts of active ingredients to achieve clinical effect. He said fake medicines directly impact on health and cause life threatening consequences.
Dr CA Sasikumar, consultant physician at Aster Medical Foundation (Aster PMF) in Kollam in Kerala, said the counterfeit medicines mainly cause damages to organs. In counterfeit drugs, the number of molecules is less, and they contain impurities. He said, since they are fake drugs, they will cause life-threatening adverse effects.
According to Dr B Mukesh, the popular diabetologist who works in Mercury Hospital in Chennai, a lot of counterfeit drugs are coming to the market everywhere. He said the Denmark headquartered pharma MNC, Novo Nordisk issued one advisory following the presence of a counterfeit of their product, Ozempic injection. He said 90 percent of the counterfeit medicines contain zero ingredients, and the remaining is fatal, but he suggested that awareness about fake medicines should be required among the public.
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