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Indian pharma is now working to further strengthen its commitment to quality, patient safety, and regulatory compliance that foster trust in ensuring the delivery of safe and effective pharmaceutical products.
The outcome of the recent Pharmexcil Bangalore Chapter congregation to deliberate on Capacity Building Programme focusing on quality compliance, patient safety and industry practices provided a perspective about the expectations of state and central drugs control departments. Also the industry experts highlighted practises in the area of QMS (quality management systems), risk assessment and skill development apart from highlighting the need for reliable excipient suppliers.
“Working closely with industry, the regulator can help to iron out issues hampering quality. Pharma industry is the mirror of the regulator as it plays a pivotal role in ensuring public confidence through transparency,” said Karnataka drugs controller Bhagoji T Khanapure.
Raja Bhanu, executive director, Pharmexcil said that pharma industry needs to comply with systems that are complicated. Nevertheless, compliance is critical and adhering to cGMP will only enable patient safety. Adhering to these practices helps prevent defects and deviations in the manufacturing process, ensuring that each batch meets specified quality standards.
Noting that attention to safety, efficacy, quality and trust are prime at a time when Indian pharma is aspiring to move up the value chain and aim at generating $130 billion by 2030, Harish K Jain, COA member, Pharmexcil and former president, Karnataka Drugs and Pharmaceutical Manufacturers Association said that there is an imminent need to innovate in a competitive global market.
“Our industry needs to align manufacturing and quality processes and facilitate easier compliance with global regulatory requirements,” added Jain who was the moderator for the panel discussion on quality compliance and patient safety.
Leading the panel discussions was Rajshekhar, DDC(I), CDSCO, Bengaluru who said that Indian pharma never lacked the trust deficit in the global pharma market. The need to ensure product compliance was the ultimate role of the regulatory authority. Following the cough syrup incidence the DGFT called for testing these liquid formulations at accredited labs. Here the CDSCO sprang into action to notify a list of recognised labs.
There were 2,000 cough syrup samples drawn of which 120 were found to be not-of-standard quality. India houses 400 adverse drug monitoring centres and 387 medical device monitoring centres. However, this is not in proportion to India’s population, said Rajshekhar.
Dinesh Mehandale, assistant vice president, QA, Relicare Tech Services an Adcock, Ingram Company, Bengaluru said that every element of quality leads to patient safety. Vendor assessment and audits are critical. There is a need to reject vendors and build pressure on them to adhere to quality products.
Anuradha Nair, associate director, lead-corporate quality, Biocon said patient safety is based on risk management which begins from molecule identification. It is here technology adoption can put away manual efforts to sustain error free tasks.
Kaushik Desai, secretary general, IPEC India said that excipients are the critical components in a medicine. There is need for a separate regulatory guideline for excipients. These needs to be seen as a drug and adhere to assessment and testing to ascertain high quality and purity.
Goutam Bhattacharya, CEO, LSSSDC Moderator, said that there is a need for a ADR (adverse drug reaction) emergency contact number on similar lines that of police and ambulance services. Besides, a legal dedicated service is much wanted for ADR issues.
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