TN pharma bodies to
approach health ministry for clarity in proposed change in product licensing
The Pharmaceutical
Manufacturers Association (PMA) of Tamil Nadu will approach the Union health
ministry and the DCGI office for clarification on its recent directive to state
licensing authorities instructing them to issue product licences only with generic
names henceforth.
B Sethuraman, the president of PMA Tamil Nadu said there is confusion in the order of the DCGI and need clarification on certain points. Regarding the period of the existing brands, the manufactures do not have any clear idea. The association has called an urgent meeting of its members in Chennai on Saturday to discuss the various issues arising out of the government decision.
His observation is that the decision of the DCGI will help neither the small scale manufacturers nor the big players. Each company, irrespective their size will have to fight for survival as everyone is trying to sell the same product.
While condemning the order of the DCGI as unwise, J Jayaseelan, the secretary of Indian Pharmaceutical Congress and the managing director of Delvin Pharmaceuticals Pvt Ltd., said the DCGI order is an outcome of irrational thinking. If the government is moving ahead with this proposal, it will only lead to more number of spurious drugs in the market, he said.
“Decision to discontinue branded products is not wise. If the brand name is disallowed, the market will not have quality products. Instead of killing the brands, government should find alternative measures to promote generics. Sixty per cent of the India’s pharma sales are carried out by big companies and 99 per cent of the sold products are branded generics. Government can promote generics, but should not kill the brands. Brand is an identity,” he said.
According to him India ranks number three in the case of volume of pharma production and number 14 in the case of value. This does not give any idea that the prices of drugs are high in the country. Compared to other countries, the drug price is less in India.
While criticising further, he said if a doctor wants to write the generic names in his prescription, he has to write a paragraph instead of small popular terms of brand names. Even the doctor himself cannot recall all the generic names of the medicines. The case of ordinary patients will be worse. He quoted an example in the case of Daonil, the anti- diabetic preparation whose generic name is glibenclamide. It will be difficult for the doctor to remember all the generic names if he has to prescribe more. The people in the lower strata of the society do identify the drugs with their colours that mark the brands.
A leading pharmacist, Jayaseelan said the new system will give freedom to the pharmacists to decide which drug should be given to the patient. The pharmacy will have several products made out of active pharmaceutical ingredients. This will force the pharmacists to substitute one product with another and they will vary in quality. A pharmacist usually prefers the one which fetches him more income, he opined.
As justification to his arguments, the leader of the IPA and IPC said, only a Pharm D pharmacist can understand and identify various generic names of the modern drugs. The diploma holders working in the pharmacies are familiar with only the brand names. No pharmacy in India has pharmacist with Pharm D qualification.
But the opinion of B Karunakaran, the president of Pharmaceutical Manufacturers Association of Pondicherry is different. He said the DCGI order will help the small scale pharma manufacturers to boost their business as the brand names developed by big companies are going to be vanished. The market will have healthy competition and the people will get the benefit, he responded.
K P Purushothaman, the president of Kerala Pharmaceutical Manufacturers Association is of opinion that the small scale units cannot withstand the stiff competition arising out of the new situation. “The decision of the DCGI will surely affect the industry. We are waiting for more details of the order,” he added.
B Sethuraman, the president of PMA Tamil Nadu said there is confusion in the order of the DCGI and need clarification on certain points. Regarding the period of the existing brands, the manufactures do not have any clear idea. The association has called an urgent meeting of its members in Chennai on Saturday to discuss the various issues arising out of the government decision.
His observation is that the decision of the DCGI will help neither the small scale manufacturers nor the big players. Each company, irrespective their size will have to fight for survival as everyone is trying to sell the same product.
While condemning the order of the DCGI as unwise, J Jayaseelan, the secretary of Indian Pharmaceutical Congress and the managing director of Delvin Pharmaceuticals Pvt Ltd., said the DCGI order is an outcome of irrational thinking. If the government is moving ahead with this proposal, it will only lead to more number of spurious drugs in the market, he said.
“Decision to discontinue branded products is not wise. If the brand name is disallowed, the market will not have quality products. Instead of killing the brands, government should find alternative measures to promote generics. Sixty per cent of the India’s pharma sales are carried out by big companies and 99 per cent of the sold products are branded generics. Government can promote generics, but should not kill the brands. Brand is an identity,” he said.
According to him India ranks number three in the case of volume of pharma production and number 14 in the case of value. This does not give any idea that the prices of drugs are high in the country. Compared to other countries, the drug price is less in India.
While criticising further, he said if a doctor wants to write the generic names in his prescription, he has to write a paragraph instead of small popular terms of brand names. Even the doctor himself cannot recall all the generic names of the medicines. The case of ordinary patients will be worse. He quoted an example in the case of Daonil, the anti- diabetic preparation whose generic name is glibenclamide. It will be difficult for the doctor to remember all the generic names if he has to prescribe more. The people in the lower strata of the society do identify the drugs with their colours that mark the brands.
A leading pharmacist, Jayaseelan said the new system will give freedom to the pharmacists to decide which drug should be given to the patient. The pharmacy will have several products made out of active pharmaceutical ingredients. This will force the pharmacists to substitute one product with another and they will vary in quality. A pharmacist usually prefers the one which fetches him more income, he opined.
As justification to his arguments, the leader of the IPA and IPC said, only a Pharm D pharmacist can understand and identify various generic names of the modern drugs. The diploma holders working in the pharmacies are familiar with only the brand names. No pharmacy in India has pharmacist with Pharm D qualification.
But the opinion of B Karunakaran, the president of Pharmaceutical Manufacturers Association of Pondicherry is different. He said the DCGI order will help the small scale pharma manufacturers to boost their business as the brand names developed by big companies are going to be vanished. The market will have healthy competition and the people will get the benefit, he responded.
K P Purushothaman, the president of Kerala Pharmaceutical Manufacturers Association is of opinion that the small scale units cannot withstand the stiff competition arising out of the new situation. “The decision of the DCGI will surely affect the industry. We are waiting for more details of the order,” he added.
SOURCE:PB
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