The Hindu : Business : Abl Bio to re-formulate product range

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Thursday, Nov 22, 2007
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Abl Bio to re-formulate product range

Special Correspondent

Spectrum, company’s arm, offers solution for developing formulations

File stability data, insists regulator
Spectrum can
help SMEs

CHENNAI: With pharmaceutical companies, especially SMEs (small and medium enterprises), going through ‘turbulent times’ in the wake of sudden regulatory changes, Abl Biotehnologies, a publicly held research intensive biopharmaceutical company, has offered to re-formulate its entire product range so as to remain in the business sans regulatory worries.

Levy of excise duty on MRP (maximum retail price), establishment of excise free zones in select pockets in the country, re-classification of over 1,250 fixed dose combination drugs, curbs on production, distribution and marketing channels in various states for these fixed dose combination drugs (FDCs) and mandatory licence from the Drugs Controller General India (DCGI) in Delhi have all posed survival problem for many SMEs, according to K. O. Isaac, Chairman and Managing Director, Abl Biotechnologies.

Addressing a press conference here on Wednesday, he said all these regulatory measures would cost the industry a tidy Rs. 3,600 crore.

The curbs on fixed dose combination drugs had already hurt the industry most with the regulator stopping them from selling these fixed dose combination drugs, insisting on them to file the stability data. “The medical community is uncertain as to what are approved FDCs and not what are not,” Mr. Isaac said. What had upset the SMEs was that the stoppage of these FDCs without even giving the mandatory notice.

Mr. Isaac said Spectrum, a division of the company, could step in to help these SMEs wriggle out of the present problem. Spectrum offers a complete solution — developing formulations, stabilising products, offering marketing strategies, providing training and making finished products — for the pharma industry.

According to Mr. Isaac, Spectrum fetches Abl Biotechnolgies revenue of around Rs. 30 crore.

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