Karnataka drugs control department is gearing up to conduct a survey of the GMP (Good Manufacturing Practices) or Schedule M compliant units across the state. The move is aimed to ensure continued compliance of GMP being maintained by the pharma companies across the state.
We hope to carry out this inspection-cum -survey in about a month’s time, DR. BR Jagashetty, Karnataka Drugs Controller told Pharmabiz.
The state’s pharma plants have been stringent in complying the Schedule M norms. This makes Karnataka to be on par with Maharashtra and Gujarat on compliance with GMP.
In fact, a number of pharma companies in Karnataka have gone way above a mere GMP compliance by bagging clearances from regulatory agencies like the 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 key factor allowing the total compliance by pharma plants in the state is the awareness about the current good manufacturing practices. Not only that, the surprise inspection on a regular basis carried out by the state regulatory authorities help units in the state to put in place systems to achieve total compliance. Further, companies also have internal audits,” said, Jatish N Seth, secretary, KDPMA and director Srushti Pharmaceuticals.
The state has around 236 pharma production plants which is a mix of multinational, large and medium-sized international regulatory compliant units.
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 possible if the unit owners did not take up the responsibility of investing in good manufacturing practices, stated Dr Jagashetty.
The state which is known for its high quality standards has not been impacted by any of the issues such as the problems encountered by Indian generic drug manufacturers in European Union or blacklisting by Nigeria government or ban by Sri Lanka on sub-standard medicines from the country.
Even during the recession in 2009, pharma exporters from the state have been able to sustain growth momentum.
There are instances of a couple of pharma plants which have not adhered to GMP. These units were issued stop production orders and eventually the licenses were cancelled. A few units which were unable to comply have shut down operations. These are Mysore Pharmaceuticals among the five others.
The state drugs control department has a team of inspectors and assistant drug controllers representing the 36 Circles carry out inspections on a regular basis.
"The need of the hour is to instil quality production norms and the practice of frequent inspections will help to maintain the highest standards in manufacturing practices,” stated Dr Jagashetty.