Karnataka pharmaceutical sector has gone beyond the standard good manufacturing practices (GMP) compliance to achieve global regulatory certifications like USFDA, UKMHRA, TGA Australia and South Africa MCC.

The main reasons to go on for international regulatory compliant units is that the standard operating procedures are enhanced which eases entry into global regulatory markets. "Constant efforts are made to upgrade the manufacturing facility with the latest production technologies with a focus on total quality, safety and environmental standards,'' stated members of the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA).

Among the existing 240 units, more than 75 percent have gone in for expansion and upgradation to grab a share of the global market opportunities. There are 70 formulations, and 60 bulk drugs units and out of these 75 have GMP certification as per WHO standards.

The units have been recognised for stringent regulatory enforcements and known to manufacture quality products. The main advantages of Karnataka's units are their visibility in national and international market, skilled workforce, capability to produce a wide-spectrum of drugs - from bulk drugs, formulations, parenterals, soft-gel capsules to sustained release formulations. Global pharma companies have already approved some units for contract manufacture and have placed several repeat orders.

The state which has a blend of multinational, large and medium sized international regulatory compliant units like AstraZeneca, Banner Pharma, Strides Arcolab, Medreich Sterilab, Micro Labs, Bal Pharma, Global Calcium, to name a few have always been known to adhere to quality standards in production.

There is no need of an extension for Schedule M as most companies in the state have realigned their business plans to suit the future requirements. The small-scale units have focused on the potential opportunities in the global pharmaceuticals and have now revamped their operations to allow international and domestic audits to tap the outsourcing opportunities, according KDPMA officials.

The fairly good compliance of Schedule M with the installation of advanced technology reflects the discipline maintained by State units in drug production, stated Suresh Khanna, pharma consultant and who held senior management positions at Kemwell and Micro Labs.