Karnataka pharma plants which have remained steadfast to Good Manufacturing Practices are now on par with states like Maharashtra and Gujarat on compliance with Schedule M norms.
Many of the state units which have risen above the GMP compliance, 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), according to Anjan K Roy, president, KDPMA and managing director RL Fine Chem,
"The main reason for the total compliance in Karnataka is due to the awareness about the quality manufacturing practices. Stringent, regular and surprise inspections were conducted between 2005 and 2007 to ensure total compliance. If any unit failed to comply, stop production orders were issued until it achieved compliance within a specified time frame," said, Jatish N Seth, secretary, KDPMA.
The state which has a mix of multinational, large and medium - sized international regulatory compliant units.
According to Dr BR Jagashetty, drugs controller, government of Karnataka, the stringent checks and surprise audits have ensured that units adhere to GMP. Therefore there is constant vigil of plants and their practices. However, achieving cent per cent compliance could not have been if the unit owners did not take up the responsibility of investing in good manufacturing practices.
However there have been a handful of units which have been not bee able to adhere to GMP. These units were issued stop production order notices and had their licenses cancelled. The companies are Pacific Pharma, Amazon Drugs and Zode Pharma, while Mysore Pharmaceuticals shut down its operations.
In order to make sure there is a regular check on the manufacturing units, the state drugs control department has a team of inspectors assistant drug controllers, who carry out inspections on a regular basis.
"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," said Dr. Jagashetty.