|
DCGI issues circular to pharma trade on proper record keeping, sourcing & sale of drugs
|
|
Nandita Vijay, Bengaluru
March 27 , 2017
|
|
|
Drugs Controller General of India (DCGI) has called on the distributors
and retailers across the pharma supply chain to evolve and adopt
strategies to ensure that drugs are procured from the authorised
channels with proper records maintained on its source and supply. The
regulator has also mandated to the pharmacy trade to share their action
plan on the same.
The move by DCGI is based on the massive
exercise of the National Survey of spurious and NSQ drugs that was
released in February 2017 which identified the certain problems related
to quality of medicines in the country.
The regulator highlighted
that retailers are the first point of call for the consumers to get
their supply of safe and quality drugs. They must ensure that drugs are
procured from authorised channels and maintain proper records of
procurement to track and trace the movement of drugs from the
manufacturer to the user. Retailers and distributors should modernise
and digitize the mechanism of procurement and inventory control of all
their operations and ensure presence of qualified pharmacists to
dispense drugs as per the norms.
Further the DCGI indicated that
the retailers should ensure storage conditions for drugs are in
compliance with the labelling provisions of the law and the quality is
maintained throughout the shelf life.
There is also considerable
importance in training of all personnel involved in distribution and
dispensing activities on the requirements of Good Distribution
Practises(GDP) including documentation.
Retailers should
quarantine and promptly notify regulators about a drug that has been
identified as suspect which means if it is spurious or not of standard
quality or potentially harmful. During instances of product recall, the
retailers and distributors must cooperate with the regulatory agencies,
stated the DCGI note.
In addition for the system of third party
inspections of retail outlets including hospitals, dispensaries,
wellness centres should be put in place systems to ensure adherence to
the requirement of GDP and Good Storage Practices (GSD).
Appreciating
the move by DCGI, JB Chowhan, chairman, Vardhaman Health Specialities
said this was long over due for the pharmacy trade sector which is the
point for quality drugs access for patients.
In the case of
Bengaluru-based Vardhaman Health Specialities, which according to the
company is the first WHO (GSDP) certified distribution company, that
sought the certification in 1988, Chowhan has now made a representation
to the DCGI to extend its expertise GDP and GSP to ensure that quality
and safe drugs are available round the clock.
“We have the
know-how and the advanced infrastructure to offer any distributor and
retailer with the cold chain facility and logistics for any time access
to drugs. During the implementation of GSP and GDP, we encountered
several obstacles like loss in business for want of reciprocal
cooperation from the stakeholders. The delays did hit our profit margin.
Nevertheless it has been a learning curve. Now with the rapid
transformation, we are keen to chip in our inputs to the pharma
distributors and retailers in the country,” he added.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|