Karnataka diabetic drug manufacturers are expanding the current formulation portfolio to increase the number of branded formulation and generic versions in the oral medications. Currently, Sulphonylureas and biguanides continue to be popular contents in the formulations, but companies are looking at extended release glipizide and sustained release metformin drugs to treat type-2 diabetes.

The four Bangalore-based diabetic drug majors: Novo Nordisk, Biocon, Micro Labs and Bal Pharma are looking at newer formulations or scouting for exclusive co-development and marketing partnership opportunities. The value of the diabetic drug market in Karnataka according to ORG is Rs 117 crore of which insulin constitutes Rs 31 crore.

On the occasion of the World Diabetic Day observed annually on November 14, drug manufacturers and endocrinologists are of the view that despite many advances in the development of oral hypoglycaemic agents, an ideal drug for treating type-2 diabetes has a long way to go.

There is extensive research being carried out globally to prevent the side-effects of diabetic drugs. In addition, ample studies are underway to assess the contraindication and non-responders of drugs, Dr. Mala Dharmalingam, professor, department of Endocrinology, MS Ramaiah Medical College & Hospital, and Director, Bangalore Endocrine Diabetic Research Centre told Pharmabiz.

The advances in research makes the field open for pharma companies in the state to tap the opportunities. Diabetes is presently the fourth leading cause of death globally after accident, cancer and cardiovascular diseases. Type-2 diabetes, which is the non-insulin- dependent diabetes mellitus represents about 98 per cent of all cases. A visible trend is the increasing number of type-2 diabetic cases becoming insulin dependent. Doctors prescribe insulin only to prevent related complications arising out of poor lifestyle control. This is where pharma companies from the state are looking to alter the pharmacokinetics of earlier molecules to offer extended and sustained release formulations of glipizide and metformin, said K Vengarai, pharma analyst.

The diabetic drug market in India is estimated at Rs 2,000 crore, of which insulin sector is Rs. 600 crore and the remaining constitutes the oral glycaemic control drugs. India has over 44 million diabetics and Karnataka accounts for one of the highest cases, according to the Research Society for Study of Diabetes in India. Rich diet, poor life style management and high stress are major causes of diabetes, which is still only manageable but not preventable, said Dr KM Prasanna Kumar, president, RSSDI.

At Micro Labs, although there were no new formulations specific to treat type-II, the focus was on diabetic neuropathy range.

Bal Pharma, which is known for anti diabetic bulk drug gliclazide, has a total formulation portfolio of 20 drugs. "Our dedicated diabetic drug division 'Glydus' contributed Rs 25 crore and our target is Rs. 100 crore by 2012," said Archana Dubey Mitra, associate vice president, API & Exports, Bal Pharma Ltd.

Biocon, which entered the biopharma space with the recombinant human insulin 'Insugen' has now moved way ahead in this space. Its oral insulin is under phase-III studies. This year, the company launched its biosimilar version of human insulin analog glargine, brand named Basalog for type-1 and type-2 diabetics. The 24-hour acting Basalog will begin 'a new era in diabetes management', said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.