New Delhi: Dr. Eswara Reddy, Joint Drug Controller of India had been arrested by CBI on Monday last with an employee of Bengaluru-based pharmaceutical company, Biocon Biologics and others in a case of bribery.
It is worthwhile to mention here that Insulin Aspart injection the root cause for controversy since it has been alleged that bribe was given to Central Drugs Standard Control Organisation (CDSCO)’s official to waive off the Phase 3 clinical trial of the medicine in India.
It may be noted that CDSCO is drug regulator that give permission for the manufacturing and sales of medicines in India after verifying their safety and efficacy for people. At the same time, phase-3 trials are done on human beings that are done to test the drugs on the largest possible sample size.
Medicare News is trying to explain the situation in relation to Insulin Aspart, its availability status in India and how it is different from other types of insulins.
As per information disseminated on its website, Novo Nordisk, a medicine manufacturing company of Denmark had promoted Insulin Aspart and this company is also the originator of this insulin. If this is innoculated it enters the bloodstream in about 2.5 minutes to help control blood sugar at meal times.
Insulin injection Aspart has been available in India under the brand name Fiasp and Novorapid that is sold on a price of range between Rs 678 to Rs 3,872. But bio-similar drugs that are of the same efficacy are of lesser price.
Now, it is important to be mentioned here that Biocon during February 2021, had announced its own bio-similar insulin Aspart namely ‘Kixelle’, which had received marketing authorisation approval from the European Commission.
Meanwhile, Biocon has also got approval for use of this drug in India. On May 18, the drug regulator CDCSO’s (Central Drugs Control Standard Organisation) Subject Expert Committee (SEC)on Endocrinology & Metabolism granted the waiver of the phase-3 clinical trial in India for Insulin Aspart during its meeting. The committee in its minutes found that the company has conducted Phase-I and Phase-III trials with the medicine in Germany and the US and based on the results of the trial, the drug has been granted marketing authorisation by European Medicines Agency (EMA) and Health Canada.
This means that Biocon was to launch the bio-similar insulin Aspart soon in India.
As per information, this insulin is very fast in action compared to its original-acting compared to its peers. It can be taken at the start of a meal or up to 20 minutes after starting a meal.
This insulin works as body’s natural insulin and facilitates the reuptake of glucose in muscles and fat cells and also blocks the release of glucose from the liver.
Biocon’s Aspart is indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged one year and above, and has been approved as a 100 units/ml solution for injection in the vial and pre-filled pen presentations.
“The maximum effect is exerted between 1 and 3 hours after the injection. The duration of action is 3 to 5 hours.”
Also, when compared to soluble human insulin, the faster onset of action of Aspart is maintained regardless of the injection site such as an abdominal wall, thigh, or upper arm.
According to Dr. Ritesh Gupta, additional director at Fortis CDOC Hospital for Diabetes and Endocrinology, “Insulin Aspart is rapid-acting insulin and its glucose-lowering action usually lasts for 4 hours. It is usually given before meals to control blood sugars.”
He added further, the conventional regular insulin takes a little longer time for being impacted. The advantage of rapid-acting insulin over conventional insulin is that these insulins are more predictable and cause less incidence of severely low sugars.”