Bringing all stakeholders together to create enabling conditions towards achieving drug quality, gamut of issues covering drug quality, ranging from labeling to packaging and storage, were discussed at the recently concluded quality summit in Mumbai organised by the Organisation of Pharmaceutical Producers of India (OPPI) in collaboration with the Department of Pharmaceuticals (DoP) and industry associations like the Indian Pharmaceutical Alliance (IPA) and the Indian Drug Manufacturers Association (IDMA).

On the occasion, government officials, industry representatives and patient groups set out an agenda to stress on the importance of setting and adopting best-in-class global quality standards for the pharmaceutical industry. Deliberations revolved around addressing quality issues among other challenges in the pharmaceutical industry.

The pharmaceutical industry faces a number of regulatory challenges. First among them is the government’s direction on not using  brand names in prescriptions, which may force doctors to prescribe cheaper, unbranded generics

Besides this, price controls will be extended to a broader range of medicines in order to cut healthcare costs. Other challenge is that the government is phasing out loan licensing - a form of contract manufacturing that accounts for 40 per cent of pharmaceutical production - because of safety concerns

There is a possibility that import duties imposed on API imports from China will also raise costs for Indian bulk drug ,manufacturers. The export market is probably the way out for the Indian pharmaceutical industry; but inspections by the regulatory authorities from the two biggest export markets, the US and Europe, highlight a number of quality issues. This puts quality high on the agenda for the industry going forward.

Commenting on the deliberations in the Quality Summit, A. Vaidheesh, President, OPPI said. “Quality is the differentiator and a key factor in competitive advantage. It is a continuous journey, not a destination. We have to keep working at it in sustained fashion. Quality of medicines are pivotal in delivering patient care and the entire pharmaceutical industry has come together to stress the importance of quality in delivering responsible and safe patient care.”

National President IDMA Deepnath Roy Chowdhury was also categorical in his position on the importance of quality medicines in India. “Our industry has taken the lead in pledging support towards making global quality medicines,” he said. “We will do our utmost in maintaining our country’s leadership in providing quality affordable medicines and ensure that indian pharmaceuticals continues to be the Nation’s Pride”.

According to a 2015 study by the Uttar Pradesh Department of Food Safety and Drug Administration, 38 percent of medicines are not effective because of low quality. This highlights the need for a baseline quality standard across the spectrum from the laboratory to the market.

India’s reputation as ‘Pharmacy to the World’ makes it incumbent upon us to achieve the acceptable quality standards across the entire value chain, from R&D to the point it reaches the patient buying medicine from the pharmacy, industry players deliberated.