Odisha Sun Times Bureau
Bhubaneswar, Oct 13:
The Associated Chambers of Commerce and Industry in India (ASSOCHAM) today urged the Odisha government for the revision of certain guidelines passed by the Odisha State Drug Control department on August 20 this year for proper implementation of existing practice by carrying and forwarding (C&F) agents, depots, super stockists and consignee agents of the state in respect of sale of drugs.
“The pharmaceutical industry is quite concerned about certain mandates issued under these guidelines that would pose practical hurdles in trade of pharmaceuticals in the state. This would be detrimental not only to the industry and trade but the patient at large”, said DS Rawat, secretary general, ASSOCHAM, in a letter to Arati Ahuja, commissioner-cum-secretary, Health and Family Welfare and HK Pradhan, Drugs Controller.
Referring to the guidelines which state that the C&F agent should not directly sell any drug to any registered medical practitioner (RMP) or nursing home or clinic, he said under Para 28 of Drugs Price Control Order, 2013, which are issued under the Essential Commodities Act, 1955, the manufacturer cannot refuse sale of any medicine asked by any distributor or dealer. These provisions have been invoked by drug authorities as well as the trade bodies when companies refused to sell any medicines, he pointed out.
Considering the above, direct sale of drugs to RMP, nursing home or clinic should be allowed to the CFAs who have valid wholesale license and the bulk quantity sale should be allowed if the wholesale license has been issued to the CFA, Rawat said, adding that direct sale to institutions are based on collective competitive prices which allow institutions to buy at the lowest price that in turn benefits the patients.
In respect of certain habit forming drugs as contained in the guideline, it is mandated that the manufacturer would print/stamp “For sale in Odisha” which is a major concern for the industry as according to the provision of DCA and Rules framed thereunder, a manufacturer cannot alter the label or obliterate a part thereof.
Further, it is practically not possible to manufacture batch for a single state due to mismatch in quantity required for a state versus batch size, Rawat pointed out.
With regard to the guidelines on sale of seasonal medicines for outbreak of unpredictable disease, he said manufacturer will be constrained to get new inventory to meet public health needs and will have to wait for new stock.
“There may be write-off of products if all inventories are not exhausted before shelf life as they cannot be allocated to other states”, he remarked.
Stating that since the pharmaceutical companies have adhered to the stringent guidelines under Schedule H1 from March this year to prevent potential misuse of such drugs under which 5 of the 6 products listed in the guidelines are covered, no such additional guidelines should be added as the industry is already fulfilling all conditions laid down under DCA, Rawat said.
Referring to the guidelines that temperature recording device should be installed in the storage area and data thereof should be preserved at least up to 2 years and air conditioning of general storage area should be made within 6 months, he said this requirement should not be applicable for storage centres/areas that keep drugs which can be stored under normal room-temperature.
“Air conditioning should not be mandated for storage areas that keep drugs which have excursion data and whose stability ensures that there is no quality concern if stored at normal room temperature. This will unnecessarily increase cost”, he argued.
Stating about the provision laid down in the guideline that that physical presence of a drug inspector would be mandatory in case of destruction of expired drugs, he said such a requirement will pose considerable hurdles in form of delays due to availability of drug inspectors for physical inspection.
“Intimation to the drug inspector before sending the materials for destruction should be sufficient as the companies are already following the requirements under DCA”, Rawat said.