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ADMA demands 10-year change-over period to comply with suffix- prefix order

Ramesh Shankar, MumbaiWednesday, March 26, 2008, 08:00 Hrs  [IST]

The Ayurvedic Drug Manufacturers Association (ADMA) will soon approach Union Health Ministry demanding a 10-year change-over time for the ayurveda, sidha and unani (ASU) drug manufacturers to comply with the ministry's recent order on suffix and prefix. The order in effect compels the ASU companies to withdraw the use of their well established brands which they have built over several decades, spending hundreds of crore of rupees. Giving a body blow to the ASU drug manufacturers in the country, the ministry had banned the use of prefixes and suffixes with the classical ASU formulation name in the ASU classical Patent and Proprietary drugs. It had asked the state licensing authorities to ban, within 30 days, such brands which are prefixing or suffixing the classical ASU formulation name but are not manufactured as per the 54 books mentioned in the First Schedule of Drugs and Cosmetics Act, 1940. Enraged over the post haste with which the ministry has asked the companies to withdraw their well established brands, ADMA general secretary Ranjit Puranik said the association will take up the issue with the ministry and will ask for a change-over period of 10 years. "The government should not extinguish the companies' rights which were legal and accepted by foreign countries just in a matter of 30 days", he said. Without mincing words, Puranik admitted that there were slight deviations from the classical formulations. The industry used alternate formulation when the ingredient was not available like in the case of Dashmool and Kasturi containing formulations. It used alternate formulation when the ingredient is endangered, banned or threatened like Praval Panchamrit and Kamadagha. Other compulsions to use alternate formulation were when the ingredient is difficult to manufacture on large scale like Rui latex and when ingredient is too expensive if Pharmacoepia is to be followed like Suvarna and Saraswatarishta-Suvarna Sakshi. Giving an example, Puranik said if Makardwaj Gutika, produced by his company Shree Dhootapapeshwar, is to be manufactured as per classical formulation, 16 times of gold have to be added which will make the cost of one tablet at Rs 400. Puranik said these products were in the market even before the promulgation of the Drugs and Cosmetics Act, 1940. These products have followed the licensing system since the time it was implemented in 1970 and have been probably gone through 30 odd renewals and still continue to find a growing consumer patronage. Moreover, these products have probably been licensed not by one SLA but by as many as 10-15 SLAs for the same product and also renewed from time to time. These companies have in fact invested more than Rs 1000 crore over the years for brand building and marketing. Moreover, these companies have also got these formulations registered with over 35 countries for exports, he said.

 
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