In what can be termed as a golden feather in the cap of Karnataka's growing pharma industry, all of the pharma companies in this state have managed to achieve cent percent Schedule M compliance and consequently find a place in the coveted list of state like Gujarat that have all the pharma units compiled with Schedule M norms.
"There are over 200 pharma units in Karnataka and all of them have managed to achieve the good manufacturing practices (GMP) certification," pointed out Dr BR Jagashetty, drugs controller, government of Karnataka.
As per the information from the state drugs control department, in 2007 there were 205 units in the state which were GMP compliant. The units which got the licenses cancelled were Pacific Pharma, Amazon Drugs and Zode Pharma, while Mysore Pharmaceuticals shut down its operations. In early 2007, certain companies received the stop production orders and they eventually went in for the Schedule M compliance.
In order to ensure there is a regular check on the manufacturing units, the State drugs control department has six inspectors and three assistant drug controllers, who will inspect the units more than once a year, noted Dr Jagashetty. "We need to inculcate the practice of frequent inspections to maintain the quality of manufacturing practices. Over the coming three months, the state drugs inspection team will conduct inspection drive to ensure that systems are in place and this will be followed by frequent checks," he added.
Besides, Karnataka Drugs and Pharmaceutical Association (KDPMA) has also made a commitment to the state drugs control department to achieve the total compliance. "The main reason for the total compliance in Karnataka is the awareness about the quality manufacturing practices. Stringent, regular and surprise inspections were conducted between 2005 and 2007 to ensure total compliance. If units failed to comply, stop production orders were issued until they achieved compliance within the specified timeframe," said, Jatish N Seth, secretary, KDPMA.
The state units have risen above the GMP compliance and many of them have achieved international regulatory approvals including US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and ANVISA (National Health Surveillance Agency, Brazil).
Apart, the export revenue from the state accounts for seven per cent of the total national pharma turnover of Rs 43,000 crore. The state's 205 units together generated revenues of Rs 2,300 crore, of which Rs 1,000 crore constituted the exports.
There is also a large volume of contract manufacturing activities going on in Karnataka. In fact, the state accounts for 40 per cent of the total business in the segment. Karnataka has impressive infrastructure and is supported by an educated workforce which supports the total compliance.
There are six listed companies in the state. They are: Strides Arcolab, Bal Pharma, Anglo French, AstraZeneca Pharma India, Biocon and Shilpa Medicare.