The United States Trade and Development Agency (USTDA) may soon initiate a project to assess the cold chain management system in India related to the logistics of drugs and biologicals, considering the increased drug imports from India and the mounting manufacturing outsourcing activity to India.

The US may soon entrust an agency to conduct the feasibility study in India, it is learnt. Recently the USTDA had roped in the US based consultant SPI USA to do the feasibility study on the cold chain practices in the field of processed foods in India. The job of the consultant was to perform the Definitional Mission (DM) for the India Cold Chain Technical Assistance (CCTA) Programme, with a USTDA fund of US$500,000 for activities like training, workshops and technical assistance to address existing weaknesses in India's cold chain infrastructure.

The agency has given its report to USTDA and the new initiative in the field of drugs and biologicals will be the second phase of the project, sources close to the development told Pharmabiz.

Though India has 100 odd US FDA approved manufacturing facilities and most of the leading drug manufacturers have their own quality logistics management systems, majority of the manufacturers doing contract work are yet to stress on developing sophisticated logistical systems and storage conditions. As a result, quality and potency of the drugs during transportation and storage may be getting affected; especially the drugs that require dedicated cold chain management. India exports drugs worth more than Rs.22-23,000 million to the US market, and of these, at least 20 per cent require cold chain management, they assess.

Sources point out that most of the biologicals like vaccines, sera, liquid cell lines and biological samples require dedicated cold chain management. One out of every three biological product requires cold chain management. However, in India, this area requires drastic improvement, as most of the drugs are stored in ordinary refrigerators.