1. WHO issues draft
guidelines on Good Pharmacopoeial Practices
The WHO has issued draft guidelines on Good Pharmacopoeial
Practices and is looking for the industry to comment before March
10, 2015. This move by WHO is being appreciated widely.
Pharmacopoeias are embedded in almost every country's national
or regional regulatory environment. The Indian Pharmacopoeia
("IP") is published in fulfillment of
the requirements of the Drugs and Cosmetics Act, 1940 and Rules
thereunder. Also, in several other Indian laws, the IP is
recognized as the standard book. A first initiative to reopen the
discussion on international harmonization of quality control
specifications on a global scale was taken in a side meeting of the
10th International Conference of Drug Regulatory
Authorities ("ICDRA") entitled:
'Pharmacopoeial Specifications – Need for a Worldwide
Approach?' in Hong Kong in June 2002. This further led to
discussions among regulators during the 11th ICDRA
meeting held in Madrid in 2004.
PSA view –The Indian Pharmacopoeia
Commission ("IPC") formed under the
aegis of the Health Ministry has issued the IP which serves as a
standard document prescribing standards for identity, purity and
strength of drugs essentially required from health
care perspective of human beings and animals. IPC keeps on
updating the existing monographs. With the release of WHO's
draft guidelines, we must revise our approach and policies towards
pharmacopoeial standards in India so as to harmonize the same, to a
great extent, with the international standards. It would be
interesting to see the comments from IPC and other industry players
on the draft guidelines.
2. NPPA Clarifies Labelling
Requirement For Scheduled Drugs
The NPPA has decided to abort its initial proposal to
implement new labelling requirements such as including
distinguishing marks and ceiling prices on the labels of every
scheduled medicine under the Drugs (Prices Control) Order, 2013,
(the "DPCO 2013"). The
industry stakeholders were discontent with the proposal as it
imposes upon them additional labelling requirements, increases
their cost of production and is likely to cause confusion among the
consumers. Thus, it was alleged that the proposal negates the
NPPA's objective to ensure effective implementation of DPCO
guidelines and empower the consumers.
Adhering to the stakeholder's suggestion, NPPA has decided
to revamp the existing reporting and labelling requirements under
DPCO and has cast certain obligations on the manufacturers and
retailers of scheduled or non-scheduled medicine in compliance with
DPCO 2013: (i) price list issued to the dealers
must be in Form V; (ii) the invoices issued by
retailers to consumers must include all the information prescribed
under Form V; (iii) the manufacturer and retailer
must give details regarding the medical composition, pack size and
price; and ; (iv) must disclose whether the
medicine is a scheduled or non-scheduled drug under DPCO 2013 and
if it is scheduled drug must also mention the current notified
ceiling price per unit (inclusive of local taxes). As regards to
implementing the distinguishing marking requirements on labels,
NPPA proposes to convene a meeting with the pharmaceutical trade
associations to design a feasible method.
PSA view – The NPPA's move is quite
praise-worthy as it aids to strike a balance between ease of
implementation for the industry and consumer education. However, it
will not be easy to ensure effective implementation of consumer
interest unless a robust information dissemination mechanism is
established. The NPPA's initiative to launch a comprehensive
in-house market database i.e., Integrated Pharmaceutical Database
Management System and Online Grievance Redressal System is still in
a nascent stage. Therefore, effectiveness of the proposal can be
decided only in times to come.
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