NEW DELHI: As the Central Bureau of Investigation (CBI) tightened its probe against officials of Biocon Biologics Limited over the alleged Rs 4 lakh bribe scandal, to waive off the Phase III clinical trial of its underdeveloped product Insulin Aspart Injection, health experts have expressed deep concerns over India’s dependency on insulin and the rising cost of this synthetic hormone.
The sensational case of bribery, involving a top drug regulatory officer and drug major Biocon Limited, has brought the spotlight to India’s diabetes problem and the race to make insulin used to manage this disease.
Health experts said that the critically-ill patients who take Insulin Aspart need to monitor their glucose level every one or two hours, whereas normal recipients require monitoring glucose routinely.
Patients using Insulin Aspart might experience weight gain and constipation. Some extremely rare but serious side effects include fast heartbeat and shortness of breath.
Biocon Biologics Limited, a subsidiary of one of India’s top biotech companies Biocon Limited, is in the news as CBI arrested S Eswara Reddy, joint drug controller of the Central Drugs Standard Control Organisation (CDSCO) and Dinesh Dua, director at Synergy Network India Private Limited, in connection with the bribery case.
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The agency had also named Praveen Kumar, associate vice president and head, National Regulatory Affairs (NRA) Biocon Biologics Limited, Bengaluru, Animesh Kumar, assistant drug inspector (ADI), CDSCO, Guljit Sethi, alias Guljit Chaudhri, director of Delhi-based Bioinnovat Research Services Private Limited along with unknown officials at CDSCO, in the case.
Being a life saviour medication, insulin injection has a lucrative market in India, because the country is home to the biggest number of diabetes patients in the world. As per studies, 17 per cent of diabetic patients reside in India.
Insulin Aspart provides relief to the patients for a short time by replacing the body-produced insulin and helping move sugar from the blood into other body tissues where it is used to produce energy. One injection typically remains effective for 3-5 hours.
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“When medicine fails and sugar level rises, insulin is prescribed for a patient. Insulin Aspart is the most commonly used drug in India. It controls sugar level in the body of a Type 1 diabetes patient within a few hours,” said Dr Anup Kumar, head of the Urology & Kidney Transplant Department of Delhi’s Safdarjung Hospital. Type 1 diabetes occurs among people of young age, he added.
Speaking to The New Indian, Dr Soumik Goswami, Faculty, Department of Endocrinology at Kolkata’s NRS hospital stated, “Insulin is a time-tested drug. It reduces glucose in the blood at every stage of diabetes. It is essentially a drug that can be used by patients when the need arises.”
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“It controls blood glucose. However, it is more expensive than regular insulin,” Dr Goswami observed.
Currently, three major drug players are manufacturing Insulin Aspart which cost somewhere between Rs 208 to Rs 600 for an injection.