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KSRPA objects to some key clauses in draft of Drugs (Sale and Distribution) Rules, 2017
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Nandita Vijay, Bengaluru
November 14 , 2017
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Karnataka State Registered Pharmacists' Association (KSRPA) has raised
objections to the draft of the Drugs (Sale and Distribution) Rules,
2017. It has stated that if the manufacturers or wholesalers are allowed
to sell directly to registered medical practitioners(RMPs) and
hospitals the spurious adulterated misbranded and not of standard
quality drugs would easily find their way to these outlets as drug
inspectors rarely inspect and draw samples from these institutions.
In
a communication to the Union ministry of health and family welfare, the
Association has said that retailers are frequently inspected and
samples regularly tested. By this amendment, registered pharmacists will
also get their legitimate share of the business chain and their
turnover increases.
It is a long pending demand of all
registered pharmacists that substitution must be permitted and made
legal. In the compounding of drugs, the registered pharmacist has the
freedom to substitute the active pharmaceutical ingredients manufactured
by different manufacturers. Registered pharmacists are also authorized
to offer consultations to the patients and doctors, in The Pharmacy Act,
1948 and The PPR, 2015. Hence it is high time, the registered
pharmacists are permitted to sell substitute drugs. Hence the Rule 11(4)
must to be deleted, said Ashokswamy Heroor, president, KSRPA.
Further,
he pointed out that in order to enable government hospitals to buy
drugs at reduced rates, sale to government may be retained in the
‘wholesale’ definition itself. In the Rule 7 (1)(iv) which refers to
power to investigate suo moto may be granted, Heroor said adding that
the word suo-moto should be added at the end. Without this addition the
drug inspector will not be able to investigate an offence noticed by him
and any oral complaint made to him, said Heroor.
“In Rule
7(1)(vi) at the end of the sentence, there is need to add the words: to
the controlling Authority. Without this addition, the controlling
authority cannot assess the work turned out by the drugs inspectors. In
Rule No: 8. Heading should include the words other than Homeopathic
medicines. In the same rule in the sub rule the words should be added as
in-charge registered pharmacist should be the proprietor or a partner
or a director of the firm. Where the working hours of the pharmacy
extends beyond 8 hours, an additional Regd. Pharmacist has to be
appointed for the period beyond the 8 hours, he said.
In Rule 9
(3)(v) which refers to the registered pharmacist's proof of registration
and its renewal should also be insisted. Separate registered
pharmacists may be insisted for retail and wholesale licenses. Rule 9
(4) (ii): In the first sentence, the words, competent person needs to be
deleted. This is because, any other persons cannot be employed in place
of a registered pharmacist. For the interpretation of the occupation,
business or trade of the applicant, it must be prescribed that the
applicant should be a registered pharmacist and should have 3 years
experience in retail sale of drugs.
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