India is mulling more regulations to reduce the use of Chlorofluorocarbons (CFCs) in metered dose inhalers (MDI) used for asthma and chronic obstructive pulmonary diseases (COPD), even as efforts are being taken to further push the ongoing campaign for the use of CFC-free alternatives in the country, in line with the Montreal protocol.
The authorities are taking views of the stakeholders to put in place regulations on priority to reduce dependence of CFC after launching the campaign for phasing out the CFCs. The ministries of health and environment would further interact with all the concerned including the pharma industry on the regulatory measures that can be introduced in this regard, sources said.
They are also weighing options including controlling the sale and distribution of CFC based MDIs and also banning manufacturing and import of CFC based MDIs with salbutamol, among other options. However, major agenda will be to evolve more mechanisms for phasing out these, it is learnt.
As a part of national awareness and outreach activities of CFC MDI phase out, a national awareness workshop on 'CFC MDI phase out transition strategy implementation and adoption of CFC free alternatives in India' will be held in Delhi on October 5. This would kick-start such information outreach initiatives which would subsequently be held at regional level based on identified high-priority areas.
United Nations Environment Programme (UNEP), in collaboration with the Ministry of Environment & Forests and Ministry of Health & Family Welfare, is organising the workshop. Officials from different ministries concerned, CDSCO, customs, representatives from CFC producers, pharma companies engaged in manufacturing and sale of CFC MDIs and CFC free alternatives, specialist organisations, NGOS, international agencies, Asthma Association, institutes and physicians are expected to attend the sessions.
India is a large manufacturer and exporter of CFC based MDIs. These products are sold in national and international markets through the pharma product distribution channels. While the health ministry regulates product registration and approval for sale in domestic markets, environment ministry monitors and controls procurement of CFCs for use in manufacturing MDIs. While CFC free alternatives were manufactured in India over the last five years, the quantities were very limited primarily on account of cost economics consideration (particularly affordability of consumer) and availability of CFC free technologies.
UNEP has been designated as a cooperating agency with a primary role in implementing awareness and information outreach component and regulations component of CFC MDI phase out project. UNEP, ministries of health and environment have decided to take help of the CDSCO as the national partner organization in the programme.
The CFC-MDI technology was first introduced in 1956 by Riker Laboratories in the United States. Since then, the use of MDIs in the treatment of asthma and COPD has been gaining acceptance. As alternatives to CFC- based MDIs, MDIs using hydrofluoroalkanes (HFAs), and dry powder Inhalers (DPIs) are commonly used for treating patients with respiratory ailments. The growth in CFC MDI usage particularly in Article 5 countries (developing countries according to the Montreal Protocol) was of concern and a series of decisions were taken on reducing CFC use in manufacturing MDIs and adopting CFC free alternatives to CFC based MDIs.