1. NPPA clarifies implementation of prices fixed under DPCO
The NPPA has recently issued an office memorandum to clarify the
doubts raised by manufacturers and retailers regarding
implementation of prices of drugs revised in accordance with the
DPCO from time to time. Para 24 of the DPCO requires manufacturers
to comply with the revised prices notified under the DPCO with
immediate effect from the date of notification by issuing a
revised/supplementary price list to the retailers and dealers. The
office memorandum issued by the NPPA on April 13, 2016 allows
manufacturers to circulate the revised/supplementary price list to
the dealers and retailers by means of e-mail, WhatsApp, etc. to
save time and submit the price list online on the NPPA website as
proof thereof. The office memorandum also clarifies that
re-calling/re-labelling/re-stickering of pre-manufactured batches
of drugs is not mandatory to implement the revised prices. However,
if the manufacturers choose to do so, they are advised to do it in
a phased manner so that it does not cause excessive shortage of the
concerned drugs in the market.
PSA view: This clarification not only helps to
resolve practical difficulties faced by manufacturers in
implementing revised prices as soon as they are notified, but also
ensures that the customer gets the benefit of revised prices with
immediate effect, irrespective of the batch number of the drugs
purchased. The revised prices have to be implemented by
manufacturers from the date of notification itself, and as per para
26 of the DPCO, drugs have to be sold at the current notified price
or the price printed on the label of the pack, whichever is less.
Therefore, even if the stock already released into the market prior
to date of notification reflects a price more than the revised
prices that have been communicated to dealer and retailers, they
will be bound to sell it at the revised prices to customers.
2. Setting up pharmacovigilance departments to be made
mandatory for companies
The MoHFW has proposed a draft amendment to Schedule Y of the
Drugs and Cosmetics Act, 1940 ("Act") to
add a new provision making it mandatory for companies to set up a
pharmacovigilance department for the post marketing surveillance of
new drugs manufactured or imported by them. This move comes as a
result of the Drug Testing and Advisory Board's
("DTAB") recommendation for improving
involvement of drug companies in testing the Adverse Drug Reaction
("ADR") of drugs sold in the Indian
market. As per the DTAB, ADR is primarily reported by hospitals and
very few companies are actively involved in it. Once this proposed
amendment comes into effect, it will be compulsory for all drug
manufacturing companies to have a pharmacovigilance department in
place, to collect, assess and formulate periodic reports regarding
the clinical safety of the drugs being manufactured and marketed by
PSA view: This is a welcome move as it will not
only ensure safety and quality control for drugs being manufactured
and sold in the Indian market, but also create more job
opportunities as the proposed pharmacovigilance departments would
require qualified and trained pharmacists to collect and process
3. Katoch Committee's recommendations finally inspires
action from the Government
India's drug market is very weak from a regulatory
standpoint. There are various drugs such as Deanxit (a drug which
is exported from Denmark but not permitted to be sold in the
country) which have been sold in India without conducting any
clinical trials. The proposed ban on 344 fixed-dose combinations
only highlights the weak drug approval system of our country. In
the month of September last year, a committee headed by Dr. V.M
Katoch, ex-Secretary, Department of Health Research
("Committee") made several
recommendations on formulation of policy on drugs manufacture
system of the country. The recommendations included providing state
of the art facilities of bulk drugs' intermediates and
manufacturers at subsidized rates and setting up state established
drug manufacture zones to boost local production of bulk drugs. The
Committee also suggested that the Department of Pharmaceuticals
should facilitate a single window clearance from Ministry of
Revenue, Ministry of Environment, etc. for drug manufacturers.
Setting up of advanced labs at all major airports and sea ports to
check the quality of imported drugs was a noteworthy recommendation
of the Committee. At present, more than 75% of India's bulk
drug imports come from China.
PSA view: With the Government finally taking
cognizance of the Katoch Committee's recommendations, the
scenario must improve. Stricter implementation of clinical trial
laws, sophisticated implementation of pharmacovigilance practices
and local production of drugs is the need of the hour.
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