UL, an independent, global safety science major, sees Indian pharma industry with the potential to hold sway in the stringent global market. The company is now increasing its partnerships in the sector with Pharmexcil to guide Indian pharma companies from compliance to performance.
Every third drug prescribed in the US is from India which speaks volumes about its capability in quality and efficacy. Indian pharma has proven its expertise exporting to both regulated and developing markets. We are keen to chip in our expertise to help pharma companies navigate complex regulatory requirements. Our intent is to ensure the Indian pharma continues its business with consistency and in complete compliance, Isabelle Noblanc, vice president and general manager, UL Compliance to Performance, USA told Pharmabiz in a telecon.
The company which offers compliance training and advisory services to pharma companies to help them become ‘FDA ready’ will now work closely with Pharmexcil to move from compliance to performance. Our strategy is to prepare the industry coming under the umbrella of Pharmexcil to prepare for future quality standards. Now trust comes with growth and companies will continue to face quality concerns in research and manufacturing which is a challenge to meet compliance. This is why we entered into an pact with Pharmexcil as the industry body’s knowledge partner and subject matter expert, she added.
Now UL will not limit its expertise to regulatory training on cGMP, SOP management, Good Clinical Practices, data integrity, CAPA, validations and inspection readiness but will conduct comprehensive international seminars, workshops or webinars on current topics to enable companies not just to be compliant but to be audit ready, said Noblanc.
Last year, at the Vibrant Gujarat Summit, UL signed a memorandum of understanding with the Gujarat government to train the Food and Drug Control inspectors on international regulatory guidelines to ensure the quality and safety of pharma products in the state. “There are further requests for fresh and repeat training from the state drug regulatory department. Now with Pharmexcil, we are engaging with the industry to create an internal compliance mechanism to confront stringent international inspections, stated Peeyush Gupta, director, sales and marketing, UL South Asia.
Considering the losses accrued by the Indian pharma sector on account of regulatory non-compliance issues, the Pharmexcil partnership is expected to equip the industry with global knowledge of compliance mechanisms and thus strengthen India’s position as the leading exporter of pharmaceuticals, noted the UL officials.
The Union government is also paving growth avenues for the pharmaceutical sector with cluster development concepts to spur opportunities in both generics and active pharmaceutical ingredients, to ensure the industry manufacturing practices are best-in-class. Therefore, we see the need for Indian pharma to move from compliance to performance under Pharmexcil partnership to remain competitive in a challenging environment, said Gupta.