Indian Regulators Working With Their Counterparts In The UK To Improve Drug Quality
Anyone who has ever entered the chaos of an Indian airport or train station knows that, despite the best intentions, service standards and product quality can be lacking.
This accusation has been pointed at Indian pharma firms in recent times, with the international market still harboring doubts as to the quality of the Indian product, with lapses in CGMP conformity a particular worry.
The good news is that things could be set to change with India having turned to more developed pharmaceutical markets for outside help. Director of the UK’s Inspection, Enforcement and Standards, Medicines & Healthcare products Regulatory Agency (MHRA), Gerald Heddell, recently declared that his organization is working with the Indian government to improve drug quality.
The memorandum of understanding (MOU) signed between the agency and the country focuses on guaranteeing the safety of products sold to the UK, but we can assume that the knock-on effect will be wider reaching.
This is what Heddell, who spoke with the Business Standard, had to say: “There have been small number of specific areas in which we have found problems. I have to say that this is not the case in majority of the companies but only in a small number.”
The reliability of data and potential of cross contamination of products is the biggest worry, and there have already been over 50 inspections made by the agency in order to address the issues.
Is There Enough Investment For High Quality Indian Drugs?
Investment looks to be a key factor in the improvement of Indian companies’ adherence to CGMP guidelines. Many facilities would have to be demolished and designed from scratch in order to accommodate safely the movement of a workforce and materials within the building.
Ensuring a quality supply of water, an expensive business in India, is another potential trouble spot for Indian pharma firms, and also requires investment in efficient water purification systems capable of withstanding a 24/7 work flow.
Initiatives like the one championed by the UK’s MHRA are a positive step, and other western agencies could potentially open up to the long term benefits of giving their Indian counterparts a helping hand.