Sale of cheap and substandard medicines by unscrupulous distributors is expected to be curbed soon with the Union government proposing to make them also accountable for drug quality.
The Drugs and Cosmetics Rules, 1945, right now holds only the manufacturer responsible for drug quality and labelling while the marketing firms need a licence to stock and sell goods. The Union Health Ministry plans to amend the rules so that the distributors too are held responsible for defective drugs.
It will have an impact on States such as Kerala where most of the drugs being sold are manufactured elsewhere.
The amendment proposes to include a clause which defines a “marketer” as “a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer for marketing of such drug by labelling or affixing his name on the label of the drug with a view for its sale and distribution.”
Marketer
It proposes to insert a rule saying that the marketer “who sells or distributes any drug shall be responsible for [the] quality of that drug as well as other regulatory compliances along with the manufacturer under these rules”.
There is also a proposal to include the name of the marketer of the drug and its address “if it is marketed by a marketer”.
Ravi S. Menon, State Drugs Controller, told The Hindu on Wednesday that over 90% of the ₹20,000-crore worth drugs being sold here in a year were being manufactured in other States.
Excise-free zones
A major portion of it comes from hilly States such as Himachal Pradesh, Uttarakhand, and Sikkim which used to be “excise-free zones”.
“Before the Goods and Services Tax was introduced, the manufacturers in these places used to enjoy Income Tax benefits too. So anyone with a licence could make manufacturers produce drugs at cheap rates and sell them here though no one could ensure its quality,” he said.
As the profits from the deal was always beneficial to the distributors, their numbers had mushroomed in the past decade, Mr. Menon said.
Punishable offence
“It was difficult to legally hold such distributors responsible for the drug quality as they may be operating from a fake address. If the proposed amendment is approved, we may be able to bring them to book,” he claimed.
The draft notification for the amendment was issued on June 24. Objections and suggestions submitted to the Union government will be considered within 30 days of the date of notification.
