It is a fact that while drug regulators worldwide are steadily increasing regulatory standards, Indian companies are finding it difficult to keep pace with the changing higher benchmarks. In the last two years, at least 25 Indian drug manufacturers were issued warning letters or faced ban on exports to lucrative markets like the US, UK and Canada. The main issue with almost all of those manufacturers was poor data maintenance.
Ernst & Young (EY) did a survey among 170 senior executives in leading Indian drug companies across business management, quality, legal and compliance, in the period January-March 2015. Some of the findings reveal how Indian drug firms casually treat data maintenance and quality assurance.
About one-fourth respondents of the EY survey were unaware of the 21 Code Federal Regulation (CFR) Part 11 standards prescribed by the US FDA, which establishes the criteria to record data in electronic form. Another 33 per cent mentioned that they shared employee login ids and passwords for laboratory systems.
Over 57 per cent of the employees agreed to have seen work pressure on manufacturing personnel to meet Key Performance Indicators (KPIs) such as volume of output, low rejection ratio and overall equipment effectiveness. About 18 per cent said they did not have adequately staffed Quality Assurance teams to review the manufacturing and testing of all the products. About 33 per cent respondents do not conduct reviews to assess potential gaps in assurance of data integrity.
"Any lapse in the assurance of data integrity is a serious deviation from expected practices and can have adverse repercussions. The EY survey is an apt reminder," says Dr. Ajaz S. Hussain, Advisor, EY and Former Deputy Director, Office of Pharmaceutical Science, US Food and Drug Administration (US FDA).
Another recent survey done by Deloitte also reveals similar trends. It surveyed 33 leading organisations including MNCs with operations in India, and found poor compliance management, internal controls, secured data and quality systems, and lack of skilled resources with most of those firms.
About 30 per cent of Deloitte's survey respondents said they had experienced non-compliance with GxP guidelines (Good - x - Practice guidelines for the pharmaceutical industry, which cover all steps from drug development to production) in the last two years. About 55 per cent of survey respondents indicated that their compliance teams were not adequately trained to address regulatory requirements. Around 48 per cent of survey respondents felt that compliance strategy was not a key area earmarked for investment in their organisations.
All these indicate that many Indian promoters do not consider quality systems as high risk with serious consequences in the event of non-compliance.
A Federation of Indian Chamber of Commerce and Industry (FICCI) report released this week notes that changes in the market landscape are throwing up new challenges. Some the big challenges facing Indian pharma today include: prices and margins coming under pressure in many markets; waning Indian core strengths of affordable costs, reliable and fast supply; poor new and complex generic drug research; regulatory issues; dependence on other countries for raw materials etc.
The trade body estimates unless these issues are resolved, Indian pharma's growth rate will halve to 8 to 10 per cent over the coming years.