Aimed at empowering the central drug regulators with the similar regulatory knowledge as offered to the US FDA officials, Central Drugs Standard Control Organization (CDSCO) is planning to equip its drug inspectors on relevant areas of current Good Manufacturing Practices (cGMP) following the online training availed by 45 officers from the Gujarat Food and Drug Control Administration (FDCA) recently.
The US-based global leader in safety science Underwriters Laboratories (UL) trained the 45 officers from the Gujarat FDCA on 22 online courses covering critical areas including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), audit-readiness and remedial training. UL offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors till date.
"There are about 15 officers in the CDSCO western region who require training on relevant areas of GMP and cGMP. However, the proposal on the same is in its final stage of approval and will materialize soon," informed an official associated with the development.
Out of the 700 courses offered through e-learning mode, 150 courses have been made available in Gujarat FDCA for the state regulators on relevant areas of GMP, GDP and validation protocols. However, there is no monetary interest associated with offering this online programme as the aim is to empower the regulators with the similar regulatory knowledge as that is offered to the US FDA.
Explains Scott Barnard, VP, life sciences, EduNeering, "As part of the MoU with Gujarat government, UL would further provide e-learning courses with different regulatory topics such as GXP (which includes good manufacturing and laboratory practices, and clinical research) to them. A system has also been provided where regulators can do those courses and track those completions."
Talking about the training module, Gujarat FDCA Commissioner Dr H G Koshia said, “UL EduNeering’s rich modules of training programmes that are followed by US FDA would definitely help our drug inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers in Gujarat.”
Last year, pharmaceutical exports from India to the United States rose 32 per cent to $4.2 billion. India accounts for about 40 per cent of generic and over the counter (OTC) products and 10 per cent of finished dosages used in the US.
Explains Dr Kavita Mehrotra, global strategic head, UL EduNeering, “UL aims at bringing in good manufacturing practices (GMP) by empowering the regulatory authorities because ultimately not only does this contribute significantly to patient safety but also influences the quality of exports of pharmaceuticals and other related products, thereby accelerating business results as well.”
“UL offers innovative technologies that prepare companies to have standardised processes, as well as audit readiness, by adhering to GMP requirements, so that the best practices exist at every level in the organisation,” explains Suresh Sugavanam, managing director, UL India and South Asia.
Workshops on GMP
The US FDA –CDSCO workshops last year covered relevant topics for Indian regulatory requirements like process validation, enforcements and computer system validation based on out of specific information. The workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad in May, 2014.
Dr Kavita Mehrotra, Global Strategic Head, UL was one of the attendees at the Goa workshop. The US FDA-CDSCO workshop, she said, was the first step towards having a shared knowledge about GMP and Quality Management Systems. “UL Eduneering will continue to act as a global thought leader in the area of GMP and CGMP, GCP and Learning Management Systems and looks forward to strengthening these ongoing efforts of US FDA to serve the India pharma community.”
UL Eduneering has the distinction to have trained 36000 USFDA drug regulators through its GMP, cGMP, enforcement and inspection focused courses authored by FDA and developed by UL Eduneering.
Additionally, these workshops were oriented towards actionable steps that need to be taken, audit readiness and basics of inspections through a thematically, strategically and ethically aligned focus with US FDA and MHRA recommendations. This is meant to enable Indian pharma companies on compliances related to consent decree, Form 483, data integrity and quality management systems. This would also provide knowledge nuggets and best practices on maintenance of electronic records for inspection-readiness of Indian companies.
Dr Margaret Hamburg, Commissioner USFDA, had made a commitment in her visit to India in February last year to launch a set of workshops to bring the knowledge of global GMP standards to the Indian pharma.
"Considering the fact that certain Indian companies have got critical global attention due to certain evasions, violations and avoidances during US FDA inspections, compliance is required for development of closed systems which captures electronic signatures, audit trails and any changes made in the system or content and also simultaneously offer, track, record and report at the same time. This is in accordance to 21 CFR Chapter 11 compliance of US FDA guidelines," Dr Mehrotra pinpoints.
To serve compliance and regulatory needs of the fast growing life science community in India, UL and US FDA have also extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending this exclusive agreement until 2019.
Medical devices and GMP
The National Symposium of Safety of Medical Devices, organised recently in association with UL in Bengaluru also deliberated upon the need for bringing in a systematic and harmonized approach towards testing for safety and efficacy of medical devices.
Medical devices manufacturing is a $350 billion global industry, with India accounting for just over $5 billion. With a population of one billion, ensuring that citizens of the country have access to affordable, quality healthcare remains a challenge.
The national symposium witnessed the launch of two reports on setting up medical device testing laboratories for electrical and electronic medical devices as well as for biomaterials and medical implants. The reports developed by the National Health Systems Resource Centre (NHSRC), in technical collaboration with the WHO Country Office for India and with technical inputs from UL in India and Sree Chitra Tirunal Institute of Medical Sciences and Technology, highlight the basic requirements, work flow, infrastructure and human resources required for establishing medical devices testing laboratories.
Speaking on the sidelines of the symposium, Ravi Capoor, joint secretary, Ministry of Commerce said, “Medical devices have a huge potential in India. However, 70 to 75 per cent of the market continues to be import based. To grow the industry and achieve the US$25 billion target, we need to lay greater emphasis on developing industry standards and making regulatory amendments to the existing Drug and Cosmetics Act. Technology can be a great enabler to these efforts and we need to set up R&D incubation centers across the country that foster innovation and thereby help in designing and manufacturing devices locally”.