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Quality is high on the agenda of senior management in drug companies operating in India, as well it should be.
After all, it has been more than established, through recent US regulatory rulings involving Ranbaxy and Wockhardt, that data integrity and basic hygiene are not issues to be trifled with — not in the domestic market, not in the export market.
Wockhardt Founder-Chairman Habil Khorakiwala said that the company has taken steps to integrate monitoring quality across its plants, a task entrusted to Managing Director Murtaza Khorakiwala.
After Ranbaxy’s third plant (in Mohali) also came under US regulatory scrutiny, Arun Sawhney, Chief Executive and Managing Director, said that it had strengthened its management, manufacturing and monitoring to ensure quality and compliance.
But companies not currently in the regulatory net are also keeping their eye on the quality goal-post. Drug-maker Cipla’s Managing Director and global Chief Executive Subhanu Saxena told Business Line recently that he has set up a quality organisation reporting directly to him.
Lupin Managing Director Nilesh Gupta explained how systems in his company get activated to ensure that employees do the needful when it comes to compliance issues. Dr Reddy’s Laboratories Vice-Chairman K. Satish Reddy agrees that Indian companies needing to tighten quality in manufacturing processes. The issue is not about individual companies, but a higher focus on quality in the Indian drug industry, he said, commenting on the fallout of US regulatory scrutiny on some locally-based companies.
But apart from the top-management, companies need to encourage people to show leadership at various levels, so that they are able to speak their minds and do the right thing, says Ajaz S. Hussain, a former FDA official and founder of US-based consultancy firm, Insight, Advice & Solutions. Transparency needs to be encouraged, so that the quality message is understood by employees and even minute details are given importance.
Regulatory dialogue
But even as companies take internal steps to minimise errors, a veteran legal expert point out that companies need to be pro-active externally too.
Top officials from companies need to be in constant dialogue with regulators, be it from India, Japan, America, South Africa or the UK, says the legal hand.
This helps companies understand what regulators are looking for and what their concerns are regarding products from foreign or local markets. After all, regulators are also human, he says, adding that they also need to be able to pick up the phone and call somebody in the company, when they want something sorted out.
Staff also need to be trained in communication, says Hussain. They need to understand what a regulator needs and they should be able to communicate with inspectors about what they are doing, he explains, indicating that sometimes the most obvious things seem to be missed in pursuit of the big picture. Indian generic drugs have made a difference in terms of affordability to people not just in the country, but several other global markets, ranging from the US and the UK to countries in Africa.
In a recent note, albeit in a different context, international humanitarian organisation Médecins Sans Frontières said that competition among generic producers in India had brought the price of medicines to treat diseases such as HIV, tuberculosis and cancer down by more than 90 per cent.
“The majority of the antiretroviral medicines purchased by the US government’s global AIDS program come from India, and more than 80 per cent of the HIV medicines MSF uses to treat more than 280,000 people with HIV in 21 countries are generics from India,” says MSF, also known as Doctors without Borders.
India has a reputation to protect in being the pharmacy of the world. So, even as it deals with the pressures of operating in a competitive and lobby-ridden pharmaceutical industry, it is in the country’s interest to put a zero-tolerance tag to non-compliance on quality.
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