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As per various news reports, the Central Drugs Standard Control Organization (CDSCO) is set to carry out testing, inspections, and audits of cough syrup manufacturers.

Earlier, the Medical Dialogues Team had reported the WHO had requested clarification from Indian authorities regarding whether the cough syrup linked to the deaths of children in India had been exported to other countries, official sources said, as reported by PTI.

In response to questions raised by the World Health Organization (WHO), the Central Drugs Standard Control Organization (CDSCO) has confirmed that three cough syrups, namely Coldrif, RespifreshTR, and ReLife, have been recalled, and none of the products were exported from India.

The children died in India over the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials told Reuters. The deaths were all linked to the Coldrif medicine, which was banned after a test confirmed the presence of the chemical on October 2.

The Respifresh and RELIFE syrups also contain diethylene glycol, according to a public alert by Gujarat and other states on Wednesday that described it as “a toxic chemical that can cause serious poisoning, including kidney failure, neurological complications and even death, especially among children”.

The World Health Organization told Reuters it had received confirmation from India on Wednesday that three contaminated syrups had been identified, and none had been exported.

“WHO expresses deep concern over these developments and emphasizes… the regulatory gap in DEG/EG screening for domestically marketed medicines in India,” a spokesperson added by email, referring to diethylene glycol and ethylene glycol.

Details of the three tainted cough syrups:

COLDRIF

Linked to the deaths of children from Madhya Pradesh, who mostly died of kidney failure in a government hospital in another state.

Manufactured by Sresan Pharmaceuticals, based in Tamil Nadu.

Found to contain 48.6% of the toxic substance diethylene glycol (DEG), far exceeding the 0.1% permissible limit set by India and the WHO.

Produced in May 2025, with an expiry date of April 2027.

The syrup has been banned, and the company owner has been arrested.

RESPIFRESH TR

Not linked to any reported deaths.

Manufactured by Rednex Pharmaceuticals, based in Gujarat.

Contaminated with 1.342% DEG.

Produced in January 2025, with an expiry date of December 2026.

The syrup has been recalled, and the company has been ordered to halt production of all medical products.

RELIFE

Not linked to any reported deaths.

Manufactured by Shape Pharma, based in Gujarat, in January 2025, with an expiry date of December 2026.

Contaminated with 0.616% DEG.

The syrup has been recalled, and the company has been directed to stop production of all medical products.

“The CDSCO has now recommended cancellation of the manufacturing license for the company. If the raw material and the finished product were tested, we could have avoided the situation, an official told The Hindu.

The official further clarified that the recent child deaths in Rajasthan were not linked to contaminated cough syrup. “Child deaths in Rajasthan have been under scrutiny and have been medically attributed to meningitis, mucositis, and acute respiratory distress syndrome (ARDS),’’ he added.

The Division Bench of Justice C. Hari Shankar and Justice Ajay Digpaul held that Roche’s species patent (IN 334397) for Risdiplam was prima facie vulnerable to invalidation under Section 64(1)(f) of the Patents Act, 1970, as being obvious in view of prior art disclosed in Roche’s own genus patent (WO 2013/119916 / US 9586955).

Risdiplam is admittedly manufactured and marketed by the appellants in various countries, including India, under the brand name EVRYSDI Risdiplam is an oral prescription medicine used for the treatment of Spinal Muscular Atrophy.

Roche, which manufactures Risdiplam under the brand name Evrysdi, alleged that Natco’s generic version infringed its subsisting Indian Patent IN 334397, valid until May 11, 2035. The company sought an interim injunction under Order XXXIX Rules 1 and 2 of the CPC, restraining Natco from selling the drug.

Roche contended that Risdiplam, though related to compounds described in its earlier genus patent, represented a distinct and novel invention deserving independent protection. It argued that the drug was not merely “covered” by the broad Markush formula of the genus patent but was a specific compound not disclosed or enabled therein.

The company submitted that the Single Judge had erred in equating “coverage” with “disclosure” and in holding the compound “obvious” without any concrete teaching or motivation to make such structural modification.

Roche emphasized that the substitution of a nitrogen atom (-N) for a carbon-hydrogen (-CH) group in the molecule involved a non-obvious inventive step and that the difference conferred significant therapeutic efficacy, making Risdiplam a new chemical entity under the law.

Natco, on the other hand, invoked Section 107(1) of the Patents Act to defend itself, arguing that Risdiplam was already covered and obvious from Roche’s earlier genus patent WO 2013/119916 / US 9586955, which disclosed a large set of similar compounds for treating Spinal Muscular Atrophy (SMA).

Natco maintained that the only structural difference between Risdiplam and Compound 809 of the genus patent was the replacement of a -CH radical with a nitrogen atom (-N), a well-known and predictable modification in medicinal chemistry based on Grimm’s Hydride Displacement Law.

It pointed out that four inventors were common to both the genus and species patents, showing that the later patent was a mere routine optimization aimed at extending exclusivity rather than a genuine innovation. The company therefore contended that the suit patent lacked an inventive step and was vulnerable to revocation under Section 64(1)(f).

The Division Bench agreed with the Single Judge’s view that Risdiplam was prima facie obvious to a person skilled in the art, particularly because the same inventors were involved in both patents.

“Something which is ‘obvious’ to a person skilled in the art would be ‘more obvious’ to the inventor of the genus patent, who would be ‘in the know’ of things,” the Bench observed.

The judges further held that allowing minor molecular substitutions to extend patent protection would amount to evergreening, contrary to the public interest in ensuring access to essential medicines.

The court stated, “

“By no means can an inventor be permitted, by making changes to an invented pharmaceutical preparation… to keep the invention out of the public domain beyond the period of life of the patent.”

While the Bench expressed reservations about whether Risdiplam lacked novelty under Section 64(1)(e), it found “no reason to interfere” with the Single Judge’s conclusion that the compound was obvious under Section 64(1)(f). The Bench reiterated that under the Wander Ltd. v Antox India Pvt Ltd principle, appellate courts should not interfere with discretionary orders unless the lower court’s findings are arbitrary or perverse. The Division Bench held;

“We do not deem this to be a fit case for interference with the impugned judgment of the learned Single Judge. The appeal is, accordingly, dismissed.”

With this, the Delhi High Court effectively upheld Natco Pharma’s right to continue manufacturing and marketing its generic version of Risdiplam pending the outcome of the main suit.

To view the official order, click the link below:

The scorecards and results of each of the 22 candidates have been deemed invalid by NBE. Similar action has been taken against 11 FMGE candidates who appeared between the same timeline.