Nineteen out of 241 units in Karnataka are expected to be shut down operations permanently for not being able to comply with Schedule M norms. These units are in the small scale segment and have received stop production orders from the Karnataka Drugs Control department. Now the state has achieved 92 per cent compliance in Schedule M, which is the highest in the country.

According to the Karnataka Drugs Control department, the bulk drug, formulation and disinfectant manufacturing units, which are likely to not to exist are three companies in Bangalore and the remaining in Hubli-Belgaum districts. The names of the units have been withheld. Their levels of operations are small and the units are in deep financial crisis. Any amount of funds infusion is unlikely to revive them. Even in the event of a major facility revamp among the 19 small units which at the moment are not in a position to meet the requirements of Schedule M, around nine of these could see the light of the day with sizable infusion of capital.

During the regular inspection drives by the state drugs control department, it was found that 45 companies were not yet complied totally to the Schedule M norms. Stop production orders were issued to the units. The non- compliance was found primarily in the areas of air handling and the bectalactum facilities required a major revamp for conformity. All the bectalactum units in the small-medium sector discontinued their production. The other units invested a few lakh of rupees to install state-of-the-art air handling devices, according to Karnataka Drugs Controller (in-charge) Prabha Kumar.

Out of the 45 units, 26 of them demonstrated their earnestness and perseverance to adhere to Schedule M. The balance 19 units have not been in a position to upgrade, pointed out Prabha Kumar.

In the event of closure, Karnataka will have a total of 222 units, out of 90 percent are in the small scale sector. The survivors in the Schedule M era have really worked towards facility revamp through major investments and chalked out strategies seek approvals for international and domestic audits for contract manufacture projects, informed Prabha Kumar.

The State has 342 loan license units which include a cross section of small-medium-large companies like Medopharma, Biochem, Remidex, Kemwell, Banner, KAPL, Strides among others.

The pharma majors in the state are Strides Arcolabs, Biocon, AstraZeneca, Micro Labs, Bal Pharma, Banner Pharma, Medreich Sterilab, Global Calcium, Hikal, Group Pharmaceuticals (Malur), to name.