Exporters from across the country have expressed concern over the demand made by many countries from the middle-east asking for Indian reference price list based on Drugs (Price Control) Order (DPCO) 2013. It is understood that Arab countries like UAE, Egypt have already sent strong signals to the Indian exporters suggesting price revivals as per the new DPCO for those drugs that are marketed in India as well as exported to these countries.

Pharmaceuticals Export Promotion Council of India (Pharmexcil) informed that considering the gravity of this issue, they have already appraised about this matter to the commerce ministry for appropriate action. Now, with the new DPCO in place, bringing more essential drugs under the price control, some countries are understood to be keen to adopt the same prices fixed by the Indian government, to ensure availability of affordable drugs to the patients in their countries.

However, this news comes as a huge setback to the Indian exporters marketing the basket of drugs in India, since they are already grappling with pricing issues within the country. Moreover, some of the companies are already flustered and have  expressed their displeasure over the larger basket of price controlled drugs in the new DPCO. Industry insiders fear that this issue if not addressed can set a precedence for more countries to take up this issue and demand the drug to be imported as per the Indian reference price in future.

Dr P V Appaji, director general of Pharmexcil stressed that the council is taking all possible measures to impress upon possible impact of this development on exports, with the commerce ministry. “We have received a lot of representation from the stakeholders expressing their anxiety and fear over this issue and we want to assure them that the ministry is always open to discussions and suggestions from the industry. On our part, we have already emphasised about the indirect adverse impact of the DPCO on the exports to the commerce ministry and are expecting to get a response from them soon on this matter,” he said.

Sources inform that the commerce ministry has already taken cognisance of this issue and may soon issue some clarification on this matter. Interestingly, the commerce ministry is said to have raised some concerns over this issue prior to the DPCO 2013, and is said to have worked along with the Department of Pharmaceuticals (DoP) while setting the prices to avoid confusion in the latter stage.

Mid-May the DoP came out with a notification replacing the DPCO 1995 with a new DPCO 2013, bringing formulations of 348 drugs under price control. The new order is based on revised National List of Essential Medicines (NLEM) of 348 drugs that will be subject to ceiling price based on simple average of all existing brands with over one per cent market share. Interestingly, there is an important clause enclosed in the new DPCO regarding discontinuation of the formulations under price control by the manufacturing units, to prevent shortage of those drugs in the market.

The new DPCO states that manufacturers intending to discontinue any scheduled formulation should issue a public notice and also intimate the Government in this regard at least six months prior to the intended date of discontinuation. As per the new DPCO, the Department will also monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients and the manufacturers have to furnish such information to the Department on a quarterly basis.