Uniform penalty policy for violation of D&C Rules: AP

The guideline specifies same penalty for same violation.

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Last Updated on March 3, 2021 by The Health Master

Finding that a uniform penalty policy is required for enforcement of  drugs and cosmetics rules (D&C Rules) 1945 in the trade sector, the Andhra Pradesh government has accorded permission to the Director General of Drugs and Copyrights to adopt Standard Operating Procedures (SoP) / Guidelines for initiating penal action against wholesalers and retailers for violation of conditions of sale licences.

As per the SoPs, the violators of drug rules will invite penalties in the same mode everywhere in the state and the enforcement officers are bound to initiate the same punitive action for any specific violation.

The guideline specifies same penalty for same violation.

With this, the state’s drugs control administration will have uniform set of procedures for prosecutions in respect of breaches of the act and rules.

Currently, because of lacunae of a common guideline for prosecution, different enforcing officers are initiating actions differently against same kind of violations.

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The SoP says that for a violation of section 65 of the D&C Rules 1945, which says personal supervision of registered pharmacists while compounding or dispensing medicines, the licensing authority can suspend or cancel the licence for seven days in the first observation of the breach and for 15 days in the second attempt.


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Similarly, if a licencee fails to display his licence in a prominent place in the premises open to the public, the penalty will be cancellation or suspension of licence for one day when the contravention is first observed and for two days in the second time.

However, the officer cannot use his discretionary power to make any change while imposing penalties.

The government order issued on last Wednesday says that adoption of SOPs is aimed at for achieving uniformity in the implementation of provisions of the D&C Rules.

Once the SoPs are in force, the sale licensing authorities can take action against violation of provisions on wholesale as well as retail licence holders.

Government hopes that the new guidelines will bring uniformity in the punishment for breach of norms.

Sources in the drugs control department say that, from now onwards, all the district sales licensing authorities in the state have to strictly implement the guidelines which are meant to ensure the availability of safe and efficacious drugs to the public.

It is said in the notification that the SoPs were drafted and forwarded to the government for consideration by the director general of the drugs control administration in Guntur.


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