The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged African lawmakers to harmonise their drug regulatory framework and recognise Indian Pharmacopoeia thereby helping Indian pharmaceutical industry to serve them better at more affordable prices.
A Harmonisation of drug regulatory framework amongst African countries will help avoid duplication of inspection of Indian manufacturing plants by officials of these countries in Africa leading to an increase in drug cost and delay in drug supply.
Recognition of Indian Pharmacopoeia (IP) in African countries will ease the business opportunities for the manufacturers. IP has been built and developed to meet the latest global standards. It is being reviewed and continuously updated incorporating the latest proven changes, said Raghuveer Kini, executive director, Pharmexcil.
33 young parliamentarians from 20 African countries visited Mumbai last week as part of third Indo-Africa Forum Summit to meet India’s leading drug maker, Cipla. Pharmexcil took this opportunity to meet young African lawmakers and brief them about importance of harmonisation of drug regulatory framework and recognition of IP.
With the support of department of commerce, Pharmexcil has initiated measures for recognition of IP by other developing countries with special efforts for SAARC and African countries. The Kenyan government had agreed to recognise IP during the inter-ministerial conference held in Kenya where the commerce minister headed the Indian delegation. Similarly, Pharmexcil invited FDA officials from Ghana, Ethioipia during IPHEX Africa and other international meetings and discussed the issue of IP recognition.
At present, Indian pharma industry exports medicines to over 226 countries globally. While exporting to overseas market the Indian companies must comply to either USP, BP or EP. While at the same time, they have to use the raw materials and manufacturer the same product as per IP standards when supplying it to Indian market.
India happens to be the largest partner as a source of medicines for Africa, accounting for 17 per cent of its total medicinal imports. With over 3,600 US FDA market authorisations being manufactured in over 700 US FDA inspected units, India offers all difficult and complex molecules inclusive of controlled release substances (eg inhalers, prefilled syringes).
Nine Indian pharmaceutical companies have manufacturing facilities in Africa. They included Sun Pharma with formulation facilities in South Africa, Egypt, Nigeria and Morocco; Lupin, Cipla, Dr Reddy’s, Aurobindo, Claris Life Sciences in South Africa, Hetero in Egypt, Cadila in Ethiopia and Strides Arcolab with facilities in Nigeria, Sudan, Cameroon, Mozambique and packaging facilities in Botswana and Namibia.