Labeling Norms For Generic Drugs Changed: Health Minister


The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey through a written reply in the Lok Sabha informed about the labeling norms for generic drugs.

In order to ensure that the consumer is well informed about the generic medicine, Ministry of Health and Family Welfare published a draft notification for public comments vide GSR 302 (E) dated 30.03.2017 for amendment of Rule 96 to provide that the proper name of the drugs shall be printed in a conspicuous manner which shall be in the same font but at level two font size larger than the brand name or the trade name, if any. It will come to force after completion of due formalities as per the provisions of the Drugs and Cosmetics Act, 1940.

Indian Drug Manufacturers Association (IDMA) was invited to the stakeholders meeting held on 12.12.2017 in Central Drugs Standard Control Organisation (CDSCO) and they conveyed their inability to attend the meeting. However, they had already provided their suggestions/ comments on the draft notification vide letter dated, 11.05.2017 which has been received in the Ministry.

#Natco Pharma seeks #USFDA Approval for #Hepatitis Drug

Drug firm Natco Pharma said it has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (USFDA).

Sofosbuvir is used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi, Natco Pharma said in a filing to BSE.

The company believes that “they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval,” it added.

For the 12 months ending December 31, 2017, Sovaldi had US sales of approximately USD 130 million as per Gilead Sciences Inc’s unaudited results released for the year ending December 31, 2017, Natco Pharma said.

Applications for r-DNA derived Drugs via #Sugam Portal Now



Through a recent notification, CDSCO has said that the filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal

The authority has decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be accepted through online mode only from 1st Feb 2018 and no offline applications will be accepted after that.

On November 14, 2015, the Central Drugs Standard Control Organisation has launched an online portal SUGAM (www.cdscoonline.gov.in) in pursuance of the implementation of E-Governance.

The notice states that a reference is also invited to the stakeholders meeting held on 10.01.2018 wherein it has been agreed upon that, filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal.

In view of above, it has been decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs shall be accepted only through online mode from 1st Feb 2018 and no offline applications will be accepted thereafter.



#NPPA Sets aside notification on Fixation of #Erythromycin Price


Through a recent notification, National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India has set aside its notification of dated 11th May 2017 in which the regulator had fixed the ceiling price of the following formulations with immediate effect.

1. Erythromycin Estolate Tablet 250mg
2. Erythromycin Estolate Tablet 500mg
3. Erythromycin Estolate Syrup 125 mg / 5 ml
4. Chloroquine Phosphate Injection 40 mg / ml (64.5mg eq. to 40mg chloroquine)

On 11th May 2017, NPPA had fixed the prices of the Erythromycin Estolate Tablet 250mg at Rs 3.02 for 1 tablet, Erythromycin Estolate Tablet 500mg at Rs 5.86 for 1 tablet, Erythromycin Estolate Syrup 125 mg/5 ml at Rs 0.53 for 1ml, and Chloroquine Phosphate Injection 40 mg / ml (64.5mg eq. to 40mg chloroquine) at Rs 1.31 for 1ml.

However, challenging the said notification, Alembic Pharmaceuticals Limited filed a petition under paragraph 31 of the Drugs (Prices Control) Order, 2013

The petitioner contended that Erythromycin formulations namely Erythromycin Tablet 500mg, Erythromycin, Tablet 250mg and Erythromycin Syrup 125mg/5ml have been shifted to Non scheduled by the  Government on 10th March 2016 and NPPA has been directed to regulate the Scheduled drugs shifted to Nonscheduled category as NON-SCHEDULED drugs under para 20 of DPCO, 2013.

Furthermore, the petitioner contended that NPPA had fixed the ceiling prices of above said Non-scheduled formulations referring to the paras 4,10,11,14,16,17 and 18 of DPCO, 2013, which is inconsistent with provisions of DPCO, 2013.

After examination government had directed NPPA  to issue revised SO within one month by excluding the formulations Erythromycin Estolate Tablets 250mg, Erythromycin Tablets 500mg and Erythromycin Syrup 125mg.5ml., which have since been shifted to non-scheduled category under Schedule-I of NLEM, 2015, and re-fixing the ceiling price of only one formulation, viz. Chloroquine Phosphate Injection 40mg/ml.

Following the notification of the government, NPPA re-examined and submitted the report to the government after that DoP stated that

“NPPA is hereby directed to set aside the SO 1526(E), dated 11.5.2017, as all the four formulations, i.e. Erythromycin Estolate Tablets 250 mg, Erythromycin Estolate 500mg, Erythromycin Estolate Syrup 125mg/5ml and Chloroquine Injection 40mg/ml, have been shifted to non-scheduled category vide SO 701(E), dated 10.3.2016.”

Below is the attachment for the same.


Voveran 1ml causes Kidney Damage: Health Ministry Recommends Toxicity Check


Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name Voveran 1 ml Injection.

Troikaa Pharmaceuticals had alleged that the painkiller injection diclofenac Sodium 75 mg/ml contains Transcutol, which damages kidneys and filed a petition in Delhi High Court against the granting of manufacturing licenses for the painkiller and allowing its marketing by Novartis AG.

Troikaa has developed and sells Diclofenac Sodium 75 mg/ml injection under the brand name ‘Dynapar AQ’, which is patented globally.

The petition stated that Themis to avoid patent infringement, is manufacturing a different version of its Diclofenac Sodium 75 mg/ml injection and Novartis is marketing it.

The petition further stated that Themis and Novartis have conveniently ignored the fact that Transcutol P is not recommended for parenteral use Regulatory bodies in US, Europe, and other parts of the world do not permit it’s parenteral use, as it is known to cause injury to kidneys.

During the hearing, the court had formed an expert panel to review the safety of Transcutol-P who gave their recommendations in favor of Troikaa. Novartis then approached the health ministry after which the second panel was formed under the Directorate General of Health Services. The second panel gave their decision in favor of Novartis.

Another panel was formed under Girish Sahni, director general, Centre of Scientific and Industrial Research (CSIR), in May after the contradictory reports on Troikaa’s allegations.

The which submitted its report on 29 December, endorsed Troikaa’s submissions. The committee also did not find any evidence supporting the claim of Novartis and Themis, two people aware of the matter said, adding that the panel has recommended that Transcutol-P be independently tested for toxicity. 

Sahni panel, A spokesperson for Themis maintained that product is absolutely safe and told , “Post our meeting with the committee sometime in July 2017, we do not have any further status on the subject from authorities, hence unable to comment.”


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