Health Talk | An explainer on guidelines to recall drugs

In February, the Himachal Pradesh government disclosed that over the past three years, 1,683 drug samples failed quality tests, in the state assembly. After this disclosure, Dinesh S Thakur, pharmaceutical expert and co-author of The Truth Pill: The Myth of Drug Regulation in India, wrote an elaborate thread on the micro-blogging platform X.

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Thakur, however, pointed out the need for recalling drugs from across the country that fail quality tests.

“…From a public health perspective, each of these quality failures should have been accompanied by a nationwide recall of the batch in question – the recall should have been publicly announced so that nobody else consumed the substandard medicine… How many of you remember hearing about 1,683 recall notices over the last three years? This is the @MoHFW_INDIA’s fault –- a recall system has been on their agenda for the last 46 years – we are yet to see one put in place,” he wrote in the thread.

In their book, Thakur and co-author, Prashant Reddy, talk about fixing accountability for complex inter-state recalls, the need for better sharing of information about Not of Standard Quality (NSQ) drugs, and follow-up with patients. They also talk about how India still lacks a robust law on recalling NSQ drugs.

In 2017, the Central Drugs Standard Control Organisation(CDSCO), India’s drugs regulator came up with guidelines on recall and a rapid alert system for drugs.

Recall and a rapid alert system

Drugs are recalled from distribution or use, including for the purposes of corrective action after quality, efficacy or safety deficiencies are reported. The quality-related defective products include NSQ and adulterated or spurious drugs. Safety and efficacy-related recalls involve adverse reactions and death due to drug consumption. Recalls also include medications prohibited under the Drugs and Cosmetics Act and those products for which product licenses are suspended or cancelled.

A rapid alert system is in place to transmit the recalls whose urgency and seriousness cannot permit any delay in transmission. Assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or harm to animals (in the case of veterinary products), consumers, operators and the environment.

These guidelines apply to all quality-defective products and all reported incidents of safety and efficacy received for all drugs, including vaccines and biological drugs. These guidelines are expected to be followed by licensees (manufacturers, importers, stockists, distributors, and retailers).

In December, last year, leading drug makers Lupin and Sun Pharma recalled products— thyroid and rheumatoid arthritis medicines respectively— from the US market due to manufacturing issues flagged by the US Food and Drug Administration (USFDA).

Recall procedures

Any batch of a product not meeting the defined quality standards has to be recalled from the market. Recall can be of two types: Voluntary recall and statutory recall.

Voluntary recall: A recall initiated by the licensee (in case of loan licensee jointly the contract giver and contract acceptor) as a result of abnormal observation in any product quality during the periodic review (internal/external) or investigation of a market complaint or any other failures.

An example is the drug manufacturer Abbott India voluntarily withdrawing all batches of the popular antacid syrup, Digene gel, in September last year.

Statutory recall: A recall directed by the drug control authorities after notifying that the product is considered to violate the laws. For example, a drug declared as NSQ by a government analyst and banned under 26A of the Drugs and Cosmetics Act 1940 (as amended from time to time)and as well as contravention of rule 104-A of Drugs and Cosmetics Rules, 1945.

Levels of recall

The level (or depth) of recall of a product or batch shall be determined based on recall classification and the level to which distribution has taken place. There are three levels of recall: Consumer, retail and wholesale.

At the consumer level, the product may be removed for the use of individuals, patients, physicians and hospitals. At the retail level, the recall includes retail groceries, pharmacies, hospital pharmacies, dispensing physicians, and institutions such as clinics and nursing homes, among others. At the wholesale level, the recalls extend to all distribution levels between the manufacturer and retailer.

Classification of recall

The classification for the recall is a numerical designation is assigned to a particular product recall that indicates the relative degree of health hazard posed by the drug as decided by the regulatory authorities.

Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a defective product will cause serious adverse health consequences or death.

Class II: A situation in which the use of, or exposure to, a defective product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III: A situation in which the use of, or exposure to, a defective product is not likely to cause any adverse health consequences.

Timelines for effective recall system and rapid alert

Based on the category of risks involved, a timeline of within 24 hours up to a maximum of 72 hours for Class I recall, for Class II recall up to a maximum of 10 days and for Class III recall up to a maximum of 30 days is allowed.

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