In line with the drug manufacturing practices followed in regulated geographies, Central Drug Standards Control Organization (CDSCO) has successfully concluded training sessions for drug inspectors on risk-based inspection and good manufacturing practices (GMP) which could help equip drug control officers with the latest GMP modalities.
Around five such training programmes have already concluded in the past one year, according to a senior CDSCO official. CDSCO had conducted 17 training programmes to train drug inspectors on carrying out GMP inspections in the year 2013-14.
At the same time CDSCO, as a part of its larger commitment towards harmonisation of global regulatory standards, is on its way to increase audits in the manufacturing units across the country towards compliance with GMP as per the requirements of the respective regulated markets.
Over the past decades, the industry has invested heavily in upgrading its manufacturing plants to match international standards. Approximately 1400 manufacturing units in India are WHO GMP certified, and over 800 are UK MHRA approved. India continues to have the highest number of US FDA registered manufacturing facilities outside the US.
The industry has strong capabilities in product development. Also, Indian pharmaceutical companies have the largest share of DMFs and ANDAs outside the US.
This is also in line with CDSCO's plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP level. A check list has also been finalised for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country.
This comes at a time when seven drug companies in India with substantial exposure to the US market, have also disclosed over the last few weeks that some of their manufacturing facility inspections had reached successful closure, signaling resumption of supplies and new product filings to the US.
Four GMP compliance reports were issued to Indian companies in 2015 compared to an average of around eight in 2011 to 2014. Thirty per cent of quality related warning letters and less then five per cent drug recalls have also been attributed to Indian companies, according to official sources.
Even as the Central Drugs Standard Control Organisation (CDSCO) is in the process of upgrading its GMP standards to meet the requirements of global regulatory markets, Form 483s issued last year to Indian manufacturing units had a high level of data integrity issues, pinpoint regulatory experts analysing the trends.
The originality of the data was not ensured and maintained which according to experts has led to data integrity issues which ought to be done on a real time basis. This has led to falsification of data and manipulations.
Regulators globally during their audit visits at Indian sites have issued in total 19 Form 483 last year as a part of their observations on data integrity with the latest made on March 3, 2016 on a leading Indian company.
Several Indian drug makers have come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.
Any product which does not comply with good manufacturing practices of overseas markets is being considered as adulterated and hence has the chance of losing the market, a senior CDSCO official said emphasizing the purpose of the inspection in the interest of patient safety at large.
“The current upgradation of WHO-GMP norms is being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices," explained a CDSCO official.
Global GMP violations have hurt India’s image as an inexpensive and reliable supplier of generic drugs in international markets. India’s pharmaceutical exports totalled about US$ 15.3 billion in 2014-15 is marginally up from the previous year’s $14.84 billion.
GMPs is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel.
The Gujarat Food and Drug Control Authority (FDCA) has also recently shortlisted 50 drug control officers to help get them training on GMP for medical devices and drugs. Training also includes Good Distribution Practices (GDP) and Good Laboratory Practices (GLP) in line with the training imparted to US FDA inspectors through a collaboration with the US-based global safety consulting and certification company Underwriters Laboratories (UL).
Gujarat FDCA has already trained 45 drug inspectors on 22 online courses through this initiative based on an MoU signed with UL during Vibrant Gujarat Summit in January 2015. UL EduNeering, the compliance education and training services business division of UL, is leading this initiative.
Other state drug controllers have also shown interest to roll out the same training programme that has been extended to Gujarat FDCA.
It is learnt that US FDA's workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with CDSCO in 2015 was well received as over 60 pharma companies participated in the workshop. The US FDA-CDSCO workshops held in Hyderabad, Goa, Chandigarh and Ahmedabad in May 2014 covered relevant topics for US FDA regulatory requirements like process validation, enforcements and computer system validation based on specific information.
India accounts for about 40 per cent of generic and over-the-counter products and 10 per cent of finished dosages used in the US. India also has the most number of US FDA approved manufacturing facilities outside the US.
IPR legal experts who are working in sync with global regulatory authorities on GMP have observed that Indian manufacturers who have been exposed to regulatory scrutiny have failed in areas related to root cause analysis and not keeping terms with the evolving current GMPs followed globally.
They have pinpointed that there is a need to modernise GMP standards when the big pharma in India looks forward at manufacturing complex generics which has a market of over $ 2 billion, according to industry estimates.
This is also in consonance with the growing number of audits to be taken up by global counterparts worldwide in the future with global regulators hiring drug inspectors for auditing sites in respective countries of engagement and operations for GMP compliance.
While companies realize the importance of building stronger quality and operations systems across their manufacturing facilities, quality systems have unfortunately not seen upgrades at a proportionate pace.
According to global regulatory observations, investigation of anomalies is one of the most frequent defect categories observed in its inspections worldwide. A direct consequence of weak investigation systems is that companies often face recurring deviations impacting product quality. Improvement in areas include problem definition, root cause analysis and comprehensive risk management processes.
Hence in general also, the global pharmaceutical industry faces the challenge of upgrading quality systems and delivering life-saving medicines simultaneously. India is no exception. Industry has seen a rise in quality sanctions in recent years. Between 2008 and 2014, the number of product recalls and warning letters received by pharma companies globally had tripled. In India too the pharmaceutical companies have had mixed success in upgrading their quality systems.