Lapses In Drug Quality - Marketers Will Also Be Accountable In India
Executive Summary
New proposed rules in India require the marketer of a drug to share responsibility for its quality along with the manufacturer.
India has proposed to make marketers of medicines accountable for the quality of their products alongside the manufacturer.
The proposed rules, notified by the Ministry of Health and Family Welfare, raise the stakes for many large Indian and foreign firms that outsource manufacturing in the country but have not generally been required to partake in manufacturing compliance responsibilities. Currently, under India’s Drugs and Cosmetics Rules, the manufacturer of a drug is responsible for product quality and liable for action in case of deviations.
The ministry notification, dated 24 June, specifies that under the planned rules any marketer who “sells or distributes any drug” will be responsible for “quality of that drug as well as other regulatory compliances” along with the manufacturer. By inference, the rules imply that marketers will be answerable for quality lapses too.
A marketer has been defined under the rules to include a person “who as an agent or in any other capacity adopts any drug made by another manufacturer” for marketing by “labeling or affixing his name on the label of the drug with a view for its sale and distribution.”
The proposed rules, currently open for suggestions or objections, also set out labeling requirements wherein marketers of a drug would need to include their name and address on the label, except if the drug is contained in an ampule or a “similar small container”, in which case only the name of the marketer would suffice.
Clarity Required On Procedural Aspects?
The pharmaceutical industry in India, in general, appears to back the new rules, with some experts saying these are long overdue and will help aid quality compliance in the country.
Sudarshan Jain, who recently took charge as the new secretary general of the Indian Pharmaceutical Alliance (IPA), which represents leading domestic firms, said that the group welcomes any move that supports patient safety and quality, but noted that “procedural/implementation aspects” of the new proposed rules are not currently specified.
“The nature of lapses covered, penalties involved etc are not currently clear,” Jain told the Pink Sheet.
The Organization of Pharmaceutical Producers of India (OPPI), which represents foreign firms in the country, was also reported in local media as endorsing the proposed rules, noting it believes that quality should be embedded in every stage of the drug manufacturing process and across the delivery chain — from the R&D laboratory to the pharmacy where the patient buys the drugs.
Fixing The Responsibility Of Marketers
Regulations to broaden the scope of responsibility for the quality of drugs in India appear to have been in the making for a while now.
Last year, India's Drugs Technical Advisory Board (DTAB), a top advisory body to the central and the state governments on technical matters, cleared a proposal to make provisions under the Drugs and Cosmetics Rules to “fix the responsibility” of persons who are marketing drugs without having any manufacturing facility, “using licensed facilities of manufacturers.” (Also see "Third Party Manufacturer Lapses – Marketers Will Need To Share Onus In India" - Pink Sheet, 31 May, 2018.)
The DTAB held at the time that marketing firms should be treated as an “agent of the manufacturer” and no plea under Section 19 of India’s Drugs and Cosmetics Act 1940 should be applicable to it.
Section 19 of the Act essentially specifies that no defense in a prosecution can be provided to "prove merely” that an accused was “ignorant” of the nature, substance or quality of the drug or cosmetic in respect of which the offence has been committed, or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.
The section, however, provides significant leeway to a person who is not a manufacturer of a drug or cosmetic or is the agent for distribution. Such non-manufacturers are not liable for flouting norms if they prove that the drug or cosmetic had been acquired from a licensed manufacturer, distributor or dealer; or that they did not know and could not, with "reasonable diligence”, have ascertained that the drug or cosmetic in any way contravened the norms; and that the drug or cosmetic, while in their possession, was properly stored and remained in the "same state as when he acquired it."