It is known for a fact that the pharmaceutical companies for the manufacture and sale of new drugs need a prior approval from the Central Drug Regulatory Department. Moreover, it is only after getting a nod from this department that the related food and drug companies are allowed to manufacture and sell these medicines. Yet, a lot of pharmaceutical companies simply carry o making new drugs even in the absence of such approval. Hence, given such a scenario, the Central Drug Regulatory department has issued a circular stating the pharmaceutical companies need to get an approval at the earliest, for which the orders have been issued to different FDAs.
Further, the Central Drug Regulatory department has instructed the FDA that they keep a tab on the companies that manufacture fake drugs without seeking an approval and take strict action against them. Such has been clarified by the FDA Joint Commissioner (Medicine) Om Prakash Sadhwani and further added that he will furnish whatsoever information is needed by the Central Drug Regulatory department. Up till now, the NPPA has busted 60 such companies that had been making new drugs without seeking any approval.