Pharmabiz
 

IDMA to engage with regulatory authorities for development of pharma industry in India

Our Bureau, MumbaiThursday, January 5, 2012, 17:45 Hrs  [IST]

Indian Drug Manufacturers Association (IDMA) is celebrating golden jubilee of its establishment, has pledged to campaign for various causes of the industry with a renewed vigour. The Association will be celebrating its golden jubilee to engage with regulatory authorities for the development of pharma industry in India by organizing a two-day conference on January 6 and 7 in Mumbai.

As the organisation enters into 51st year, IDMA has prioritised several issues of immediate concern to the industry for which it has initiated active dialogues with the government. These issues include: Barcoding in pharma products; Chinese competition for the Active Pharmaceutical Ingredients (API) market; Pharma pricing; Allowance of 100 per cent FDI in pharma market; Directing the competition council to all M&A proposals; Revival of pharma industry in the state of Maharashtra, and Ensuring easy passage of Indian generics to Japan.

The IDMA has called on the government to consider the barcoding initiative’s enormous regulatory, technical and cost implications for the industry and warned of the harm that these would do to India's pharmaceutical exporters, particularly to small and medium-sized enterprises (SMEs). “We would like the government to give serious consideration to providing financial assistance to help companies, especially SMEs, to cover the extra investment and cost needs to comply with the requirements. These extra burdens include a 20 per cent productivity loss and increased monthly costs including Rs.20,000 in additional registration expenses and Rs.10-15 lakhs a capital cost as assembly line, for barcoding accessories such as inks,” said NR Munjal, president, IDMA.

“IDMA has suggested to the government to issue stringent inspection norms and impose anti-dumping duties wherever necessary. We would also like to set up dedicated API and basic chemicals fund of $700 million to help small and large API manufacturers,” said Manish Doshi, incoming president, IDMA.

IDMA has made representation to the government that 100% FDI should be allowed as the Indian industry needs huge investments to meet R&D costs, brand building costs, state-of-the-art production facility costs etc. It also strongly feels that a competition commission could be directed to review all major M&A proposals to ensure and pacify concerns that monopolies are not created by takeovers thus influencing competition and price rises. This along with constant price monitoring by NPPA would adequately protect the consumer interest, said Daara B Patel secretary-general, IDMA.

“Also IDMA is constantly urging the state government for better infrastructure, more number of special economic zones, and better performing Common Effluent Treatment Plants (CETP), to introduce more pharma clusters and funding support, and less bureaucratic hurdles, less number of inspection hurdles. Compared to other states, the FDA in Maharashtra has more number of unwanted procedures compared to other states,” said Patel.

 
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