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Karnataka pharma comes out clean in the national raid by DCGI to unearth spurious and NSQ drugs
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Nandita Vijay, Bengaluru
March 30 , 2023
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The pharmaceutical industry in Karnataka has emerged unscathed in the nation-wide raid conducted by the Drugs Controller General of India (DCGI) at the manufacturing sites across the country to unearth spurious or substandard drugs.
According to BT Khanapure, drugs controller, government of Karnataka, this is a feather in the cap for both the pharma industries and the regulatory officials in our state who have stood up the test of time. Our enforcement teams have left no stone unturned during their surprise and regular inspections across production plants in the state. This has been a key reason for industry to be constantly adhering to quality production practices.
The state has 425 manufacturing units. Companies from here contribute 10 per cent to the country’s exports. At least 10 major brands are manufactured by Karnataka pharma companies which is a clear indication of the dependability on quality and timeline deliveries. Therefore, a licensing authority is mandated to approve drugs in a time-bound manner and we have stuck to this task ensuring strict surveillance to spot only highest quality manufacturing is undertaken, Khanapure told Pharmabiz.
The companies here represent a cross section of the pharmaceutical production milieu. They have the expertise and knowhow in active pharmaceutical ingredients (APIs) formulations and contract manufacture. While India is known to have the highest US FDA plants outside the US, Karnataka companies have been certified by several global regulators.
The state pharma companies comply with highest quality standards which is integral to safeguard public health. The drugs control enforcement wing also sees that the percentage of not-of-standard quality locally manufactured drugs is comparatively less compared to the national percentage. For instance, in 2021-2022, of the 307 medicines declared not-of-standard quality, 275 drugs are manufactured outside of Karnataka. This indicates the quality performance of companies in the state, he added.
“Our department’s effort is to strive for excellence in pharmaceuticals and ensure good health for all by ensuring access to safe, high quality and efficacious medicines, medical devices and cosmetics,” said Khanapure.
Noting that quality is key, he said we need to revolve all our efforts around this. It is here our regulations mandate Good Laboratory Practice (GLP) regulations, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) which companies across MSMEs and large enterprises are seen to adhere.
Karnataka is home to three drug testing labs with an installed capacity of 84 HPLCs, GC and AAS. Our advanced sterility testing facility is located across Bengaluru, Belagavi and Hubbali. Therefore it gives the pharma industry to take advantage of this and maximise these to the best of their ability to maintain its highest quality standards, said Khanapure.
Being the Information Technology capital of the country, there is adoption of technology by the companies in Karnataka like artificial intelligence, analytics, Internet of Things (IoT), data integration platforms, cloud content management and information security provides transparency. Moreover, Pharma 4.0 is evolving. The architecture of plant floor applications such as MES (Manufacturing Execution Systems), scheduling, maintenance, quality, automation, and IIoT (Industrial Internet of Things) provide the agility the manufacturers need. Companies in the state implementing digitalization and automation are well prepared to monitor quality production steps.
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