India’s apex drug regulator took 12 days after an alert from the manufacturer to issue a public advisory announcing the nationwide voluntary recall by Abbott India of all batches of Digene gel produced in its Goa facility.

The Central Drugs Standard Control Organisation generated the advisory, which says “the impugned product may be unsafe and its use may result in adverse reaction(s)”, on August 31.

Twelve days earlier, on August 12, Abbott had sent intimation to the CDSCO about its voluntary recall.

The advisory posted on the CDSCO website on September 5 has asked consumers to discontinue using Digene gel made in the Goa facility, directed distributors to remove all batches of the product from Goa, and urged doctors to report any adverse events linked to the product.

Pharmaceutical sector analysts say the lag between Abbott’s intimation about its recall and the CDSCO’s advisory exposes the regulatory authority’s slow response to alert consumers about any medicines they should not use.

Digene is a popular antacid available without prescription. Abbott had told the CDSCO on August 18 that it had initiated a “voluntary recall of all batches of Digene gel of all flavours (mint, orange and mixed fruit) manufactured at its Goa facility”.

An Abbott spokesperson told The Telegraph on Wednesday that the company had last month initiated the voluntary recall of Digene gel made in its Goa facility, after “isolated customer complaints on taste and odour”. The spokesperson also said there had been no reports of health concerns from patients relating to the recalled product.

Abbott also manufactures Digene gel at another plant in Himachal Pradesh that remains available in the market across the country. “Other forms of Digene, such as tablets and stick packs and the Digene gel manufactured at our other production site, have not been affected and continue to be available in sufficient quantities to meet current demand,” the spokesperson said.

Queries from this newspaper to the CDSCO about the lag between Abbott’s alert about its recall and the CDSCO’s advisory and the root-cause reasons, if known, for the unusual taste and odour leading to the product’s recall have not evoked any response.

Since Abbott had already initiated the voluntary recall of the product across its network of distributors and retailers since August 18, an industry executive said, the CDSCO’s public advisory would effectively be “useful” only to consumers, patients and doctors.

“Only the CDSCO can say why it didn’t caution the public about the recall earlier,” the executive said.

Abbott first alerted the CDSCO about its decision to recall one batch of mint-flavoured Digene gel and four batches of orange-flavoured Digene gel on August 11. The CDSCO advisory cited a consumer complaint about “bitter taste and pungent odour”.

A week later, on August 18, the company told the CDSCO that it had initiated the nationwide voluntary recall of all batches and all flavours of Digene gel produced in Goa with an active shelf-life.

“Under existing drug laws, the CDSCO does not have powers to recall products with such deviations,” said Chandra Gulhati, a pharmacologist and editor of the Monthly Index of Medical Specialities, India, a trade periodical. “The CDSCO can issue orders for recall only for fake drugs, punishable by law.”

Neither the CDSCO nor Abbott has explained the root cause for the bitter taste and pungent odour.

Gulhati said he would be speculating but it is possible the company had withdrawn all batches of the product as a precautionary step under concerns about its reputation.