Biocon gets CDSCO nod for generic diabetes drug
New Delhi: Biocon on Tuesday said it received approval from the government authorities for a generic diabetes medication – Liraglutide drug substance. Itswholly-owned subsidiary Biocon Pharma has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India (CDSCO).
The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing. "The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated.
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The MHRA said Mounjaro may reduce the effectiveness of oral contraceptives such as the pill in people who are overweight, and that women taking the medication should use barrier contraceptives such as condoms, according to a report in The Guardian. The UK watchdog said it had received 26 pregnancy-related reports for Mounjaro. "These are powerful medications meant to treat serious medical conditions. They should not be used casually or bought from unregulated sources like beauty salons or social media," said Dr Alison Cave, Chief Safety Officer at MHRA. Women are being advised to use effective contraception while on these medications and in some cases for up to two months after stopping them. This is because there isn't enough data to confirm if these drugs are safe for the baby during pregnancy. Forms of contraception include: Oral contraceptives (the pill) Non-oral methods like condoms, the coil, or implants However, Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. That means women using Mounjaro should also use a non-oral method of contraception, especially in the first four weeks of treatment or after a dose increase. Another rare but serious risk of GLP-1 medicines is acute pancreatitis, which is inflammation of the pancreas. A warning sign of this is severe stomach pain that moves to the back and doesn't go away. Anyone who feels this should get emergency medical help. The MHRA also reminds users: These medicines must be prescribed by a healthcare professional. Do not buy them online or from beauty clinics, it is illegal and dangerous. Talk to your doctor before starting the medicine to understand risks and benefits. Let your doctor know if you're using one of these medicines before any surgery. Report any side effects through the Yellow Card scheme, which collects safety information on medicines in the UK. The watchdog also warned against extracting leftover medicine from used syringes. Dispose of them safely after completing the recommended doses, the statement read. These reminders come amid rising concerns that many people may be misusing these injections without knowing the full risks, especially women who may become pregnant. Staying informed and cautious is key to using these medicines safely. Join our WhatsApp Channel
