The pharma manufacturers are avoiding the use of ephedrine and pseudoephedrine, APIs used in the finished formulations as a bronchodilator, decongestant and anti asthmatic, to avoid high handed actions from the authorities as per NDPS Act, 1985.

The manufacturers have to maintain lots of details of API manufacture, purchase, storage, consumption to the usage and the slightest mistake in the record keeping lead to the violation of NDPS Act and the manufacturers are put behind the bar for 10 years. The fear of the unwanted and strict action from the authorities has become a major detriment for the industry, trade, transport and also to doctors prescribing these medicines.

Daara B Patel, secretary of Indian Drug Manufacturers' Association (IDMA) informed that the ephedrine and pseudoephedrine are good products for medicinal use. Just because of the harsh action taken for the procedural lapses, the manufacturers are avoiding the use of ephedrine and pseudoephedrine, which is leading in the shortage of the formulations. But the API manufacturers are manufacturing enough quantity and they are exporting it because of the overseas demand.

He further says, “It's a such a big market as India is the major manufacturer of these APIs and it was a very good product for the patients. The NDPS Act which is being enforced here has no clarity and there is no single agency which take care of this particular range of product. There should be an amendment in the NPDS Act and fine and penalties should be introduced for the procedural lapses.”

India is a major manufacturer of ephedrine and pseudoephedrine and exports to over 60 countries with over 50 per cent of the world market share. As per the report by International Narcotics Control Board on April 08, 2016 the annual legitimate requirement of ephedrine and pseudoephedrine in the world is 249 metric tons of ephedrine and 1538 metric tons and India manufactures approximately 500 metric tons of I-ephedrine and 300 metric tons of D- pseudoephedrine annually.