Karnataka State Registered Pharmacists Association(KSRPA), Gangavati in Koppal district has taken serious objection to the hefty fine for violations amounting to Rs.50,000 and Rs.5 lakh proposed on chemists and druggists in draft D &C amendment 2015.
The Association has stated that the Rs.5 lakh fine is for errors in billing which covers date, signature, amount and batch number. This should be brought down to Rs.25,000 because it is too hefty for a pharmacy trade outlet.
Referring to the amendment in the section 27A of the principal Act, under ‘iii’ which states any drug or cosmetic deemed to be misbranded under section 17C, would be liable for penalty that could be extended to Rs.50,000 and would be imposed by the State Licensing Authority. Ashokswamy Heroor, president, Karnataka State Registered Pharmacist’s Association told Pharmabiz that the government will need to bring about a change to this levy. This is because the chemists and druggists cannot be responsible for the misbranded drugs because it is the sole responsibility of the pharmaceutical manufacturers. These drugs are transported from pharma company depots to the C&F agents after it enters the supply chain of stockists/wholesale distributors and to retail stores.
“Further, pharmacy outlets also cannot be held accountable for the substandard drugs because it is onus of pharma manufacturer. When the Court orders investigation on the violations, pharmacy outlets are forced to cough up fines even if it is entirely due to a manufacturing error. We see this fine related to 17 C is exorbitant and therefore should be nil for the pharmacy trade,” he added.
The licensing authority should inspect on pharmacy outlets and enforce punishment only if they fail to have a qualified pharmacist present at the counter, entertain prescriptions of quack doctors or sell Schedule H drugs without a prescription, absence of adequate storage requirements and non compliance to licensing conditions, said Heroor.
Under Section E of the Amended Act, the government has said that any cosmetic, other than a drug referred to in clause (i) or clause (ii), in contravention of the any other provision of this Chapter or any rule made under the Act, will be liable for penalty that many extend to Rs.2 lakh imposed by the State Licensing Authority.
Heroor points out this fine is too hefty for small chemist and must be reduced to Rs.25,000 . This is because these are primarily unintended human errors related to date, inaccuracy of signature, slip-up during the entry of the drug price and blunders in noting batch numbers.
Commenting on the section 28B of the principal Act, where the government mandates punishment less than three years and with a fine liability of Rs.5 lakh, Heroor says the daft amendment of the D&C Act indicates discrepancies in the penalty for section 28 and 28A where it is only Rs.3 lakh. In the case of 28B the payment is Rs.5 lakh. “We need the enhanced punishment to be fixed,” he noted.
In its 33 point representation to the government, KSRPA has also pointed out that the provisions related to ayurveda have to be shifted to Section 3(a), 3(d)(iii), 3(g) and 3(za)(i). The new Ayurveda drugs have to be defined and clinical trials need to be fixed for them.