India has been witnessing the trend of steadily increasing import of APIs, intermediates and excipients from China at very low prices for some years now. While the formulation industry felt happy in sourcing cheaper Chinese APIs, the bulk drug industry in the country has been objecting to such imports as that started hitting the very existence of bulk drug units here. According to the Department of Pharmaceuticals, almost 40 per cent APIs required in the country are being imported from China. Although the formulators were getting benefited by cheaper imports of APIs from China, the government was concerned as these imports were posing a threat to domestic API industry. In fact many small and medium scale API units had closed down during the last five years. It was in the background of this scenario, the Department of Pharmaceuticals sought stern measures including anti dumping duty on API imports from China. Even these attempts from the government did not yield the desired results and Indian bulk drug industry continues to suffer. It has to be remembered that India had emerged as a leading producer and supplier of quality APIs to the global pharma industry only two decades ago.
Apart from cheaper imports affecting the domestic bulk drug industry, poor quality of APIs and intermediates coming from China, of late, is causing serious health issues in India as these APIs are used for the manufacture of formulations marketed in the country. To ensure only quality APIs and other materials are imported into India, the health ministry had started the exercise of checking the GMP facilities of foreign manufacturing sites some time back. Six bulk drug manufacturing units in China were inspected in May 2011. Registration Certificate and Import License of one unit inspected was cancelled. Again in March 2012, four manufacturing units in China were inspected and in one case, registration certificate was cancelled. But the problem persists and substandard materials are somehow still reaching the Indian formulators. In fact, some of the traders are even importing large quantities of bulk drugs claiming them as intermediates. It is quite possible that one of the reasons for recent rejection of some batches of generic drugs from India by the US and Europe is on account of the use of substandard APIs imported from China for their export production. The Drugs Technical Advisory Board has already asked the DCG(I) to ensure that the imports into the country should be permitted only after ensuring that the documents submitted by the manufacturers are authentic and duly verified. The issue calls for tough action against such imports for the very existence of Indian pharmaceutical industry and health of the people of the country.