World pharmaceutical industry should have received a severe shock last week when Therapeutic Goods Administration (TGA) of Australia ordered recall of over 1,400 vitamin and herbal products of Sydney-based Pan Pharmaceuticals from its market. TGA also suspended manufacturing licence of Pan Pharmaceuticals for six months, which caused the resignation of its managing director in three days. Never in the history of world pharmaceutical industry a regulatory authority of a country had to order recall of so many products of a leading domestic pharma company. TGA action comes in the wake of a number of serious safety and quality breaches such as substitution of ingredients, manipulation of test results and substandard manufacturing processes by the company. Subsequent to TGA order, retailers all over Australia removed the entire stocks of Pan products in two days. Drug authorities in Newsland, Malaysia and Singapore have also ordered withdrawal of Pan products from their trade channels now. Which other countries have been importing and using Pan products is not immediately known. An important task that remains to be completed by TGA is to identify products, which were being manufactured at Pan's facilities for other pharmaceutical companies. Pan has been a leading contract manufacturer for several branded products.
A recall of products of this magnitude and cancellation of manufacturing licence could lead to a certain financial collapse of this international pharma company soon. But the damage that might have caused to the health of so many people in various countries is much more serious. And the responsibility for that is solely on TGA. How such a serious lapse on the part of TGA could happen for a long period of time is a matter of serious concern for health professionals and informed public world over. Implications of this development should also be a matter of worry to countries where regulations on herbal products and food supplements are absent or lax. India is one such country. The proposal to bring in legislation for licensing and registration of these products in this country has not made any progress after years of deliberations by various government agencies. Thousands of herbal and vitamin products falling outside the category of drugs are thus being freely marketed in the country today by Indian pharma companies and some international companies without any checks and controls. Indian public is blissfully unaware of the safety of these products and what adverse reactions these products are causing to them. As it is, the system of recall of drugs is highly ineffective in India despite Central Drug Standards Control Organisation issues orders of ban and recall of unsafe drugs occasionally. One recent case is that of astemizole and terfinadine. Although CDSCO banned their manufacture and sale effective from April 1, 2003 the products are still being freely sold in retail counters across the country.