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.”


#USFDA Warning Letter to German Drug Firm for Baddi Plant


US health regulator USFDA has issued a warning letter to German drug firm Fresenius Kabi AG for
lapses at its drug manufacturing facility at Baddi in Himachal Pradesh.

In a letter to the company’s CEO Mats Henriksson summarising violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, United States Food and Drug Administration (USFDA) said it had conducted inspection of the Baddi facility from April 6 to 14, 2017.

“Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed,” the health regulator said.

While saying that it had reviewed company’s May 10, 2017, response in detail and acknowledges receipt of its subsequent correspondence, USFDA asked the drug firm to provide plans and procedures to ensure that future sterility failure investigations included a more thorough review of long-term trends.

The regulator also asked Fresenius Kabi AG to ensure sufficient investigation of potential vulnerabilities in the manufacturing operation and potential correlations with past incidents.

The letter also said that in an inspection from May 14 to 22, 2015, FDA had cited a similar CGMP observation in which the company invalidated sterility test failures without adequately investigating the root causes, and failed to take timely and appropriate corrective actions.

“Although you proposed remediations in your responses following the 2015 inspection, and discussed these plans during a 2016 regulatory meeting with the Agency, our current inspection found that your facility’s oversight and control over the manufacture of drugs remains deficient,” it added.

Recommending engaging of CGMP Consultant, USFDA said based upon the nature of the violations it strongly recommended engaging a consultant to assist the company in meeting CGMP requirements.

The regulator said until the company corrects all violations completely and “we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”

Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Fresenius Kabi Oncology at Baddi in the United States, USFDA said.

51 Essential Drugs under #NPPA Price cap,check out details


National drug pricing regulator NPPA on Friday said it has capped prices of 51 essential formulations, including those used for the treatment of cancer, pain, heart conditions and skin problems.

The prices have been slashed in the range of 6 to 53 percent.

In separate notifications, the drug price regulator said it has notified ceiling prices of 13 formulations while revising the same for 15 formulations.

Moreover, retail prices of 23 essential formulations have also been notified, National Pharmaceutical Pricing Authority (NPPA) said.

Drugs whose ceiling prices have been capped includes colon or rectal cancer treatment drug oxaliplatin (injection 100mg), Japanese encephalitis vaccine and measles rubbela vaccine.

On the other hand, ceiling prices of drugs including anesthetic sevoflurane, Phytomenadione (Vitamin K1) and tuberculosis prevention medicine BCG vaccine have been revised.

According to highly placed sources in NPPA, the reduction in prices following the latest exercise will range between 6- 53 percent.

NPPA fixes ceiling price of essential medicines of Schedule I under the Drugs (Prices Control) Order (DPCO) 2013.

In respect of medicines that are not under price control, manufacturers are allowed to increase the maximum retail price by 10 percent annually.

The calculation of essential drugs is based on the simple average of all medicines in a particular therapeutic segment with sales of more than 1 percent.

Set up in 1997, NPPA has been entrusted with the task of fixation/revision of prices of pharma products, enforcement of provisions of DPCO and monitoring of prices of controlled and decontrolled drugs.

Following are the details:

Sl. No.
Name of the Scheduled
Formulation
Dosage form & Strength
Unit
Ceiling Price
(Rs.)
(1)
(2)
(3)
(4)
(5)
1.
Oxaliplatin
Injection 100mg (as licensed)
Each Pack
4055.10
2.
Acetylsalicylic acid
Effervescent/ Dispersible/ Enteric coated Tablet 100 mg
1 Tablet
0.1625
3.
Japanese Encephalitis Vaccine
4mcg to 6mcg
Each Pack
632.95
4.
Japanese Encephalitis Vaccine
up to 3mcg
Each Pack
482.22
5.
Measles Rubbela Vaccine
Each Pack
(0.5ml)
80.22
6.
Surfactant
Suspension for intratracheal instillation (As liensed)
Per mg of Phospholipids in the pack
60.69
7.
Sevoflurane
Inhalation
1 ml
24.12
8.
Acetylsalicylic acid
Tablet 325mg
1 Tablet
0.50
9.
Desferrioxamine
Powder for Injection 500mg
Each pack
145.91
10.
Oxaliplatin
Injection 50mg
(as licensed)
Each Pack
2303.01
11.
Phytomenadione (Vitamin K1)
Injection 10mg/ml
1 ML
43.45
12.
Glutaraldehyde
Solution 2%
1 ML
0.05868
13.
Anti-D immunoglobulin
Injection 300mcg
Each Pack
1936.82
14.
BCG vaccine
Each Dose
4.32
15.
Morphine
SR Tablet 30 mg
1 Tablet
4.94
16
Alteplase
Powder for Injection 20 mg
Each Pack
17235.00
17.
Alteplase
Powder for Injection 50 mg
Each Pack
35985.00
18.
Gadobenate
Injection 529 mg/ml
1 ML
98.90
19.
Haemodialysis fluid
As license
1 ML
0.03695
20.
Furosemide
Oral liquid 10 mg/ml
1 ML
0.29
21.
Glucose
Injection 50%
1 ml
0.44
22.
Lignocaine (A) + Adrenaline (B)
Injection 1% (A) + 1:200000 (5 mcg/ml) (B)
1 ML
0.41
23.
Calcium gluconate
Injection 100 mg/ml
1 ML
0.50
24.
Dextran-40
Injection 10%
1 ML
0.38
25.
Coagulation factor IX
Powder for Injection 600 IU
Each Pack
11,180.00
26.
Digoxin
Oral liquid 0.05 mg/ml
1 ML
0.29
27.
Potassium permanganate
Crystals for topical solution
1 gm
0.40
28.
Pilocarpine
Drops 4%
1 ML
10.60


Sl.
No.
Name of the
Scheduled
Formulation
/ Brand
Name
Strength
Unit
Manufacturer &
Marketing
Company
Retail
Price (Rs.)
(1)
(2)
(3)
(4)
(5)
(6)
1.
Sofosbuvir & Velpatasvir
Each film  coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg
28 Tablets
M/s Hetero Labs Ltd. / M/s Abbott India Ltd.
15625.00
2.
Sofosbuvir & Velpatasvir
Each film  coated  tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg
28 Tablets
M/s Hetero Labs Ltd. / M/s Cadila Healthcare Ltd.
15625.00
3.
Sofosbuvir & Velpatasvir
Each   film coated  tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg
28 Tablets
M/s Natco Pharma Ltd. /M/s Sun Pharmaceuticals Industries Ltd.
15625.00
4.
Sofosbuvir & Velpatasvir
Each film   coated   tablet contains: Sofosbuvir 400mg,
Velpatasvir 100mg
28 Tablets
M/s Natco Pharma Ltd. / M/s Cipla Ltd.
15625.00
5.
Sofosbuvir & Velpatasvir
Each film coated    tablet contains: Sofosbuvir 400mg,
Velpatasvir 100mg
28 Tablets
M/s Natco Pharma Ltd.
15625.00
6.
Sofosbuvir & Velpatasvir
Each film coated  tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg
28 Tablets
M/s Natco Pharma Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd
15625.00
7.
Sofosbuvir & Velpatasvir
Each tablet  contains: Sofosbuvir 400mg, Velpatasvir 100mg
28 Tablets
M/s Dr. Reddy’s Limited
15,625.00
8
Sofosbuvir & Velpatasvir
Each tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg
28 Tablets
M/s Hetro Labs Ltd.
15,625.00
9.
Voglibose + Metformin
Each tablet contains: Voglibose 0.2mg, Metformin 500mg
1 Tablet
M/s Lupin Ltd.
4.84
10.
Voglibose + Metformin
Each tablet contains: Voglibose 0.3mg, Metformin 500mg
1 Tablet
M/s Lupin Ltd.
5.76
11.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 1mg
1 Tablet
M/s Lupin Ltd.
7.14
12.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 1mg
1 Tablet
M/s Sanofi India Ltd.
7.14
13.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 1mg
1 Tablet
M/s Biocon Ltd.
7.14
14.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 2mg
1 Tablet
M/s Lupin Ltd.
9.05
15.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 2mg
1 Tablet
M/s Sanofi India Ltd.
9.05
16.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.2mg Metformin 500mg Glimepirid 2mg
1 Tablet
M/s Biocon Ltd.
9.05
17.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.3mg, Metformin 500mg, Glimepirid 1mg
1 Tablet
M/s Lupin Ltd.
8.52
18.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.3mg, Metformin 500mg, Glimepirid 1mg
1 Tablet
M/s Alembic Ltd.
8.52
19.
Voglibose + Metformin + Glimepirid
Each tablet contains: Voglibose 0.3mg, Metformin 500mg, Glimepirid 2mg
1 Tablet
M/s Lupin Ltd.
10.46
20.
Diclofenac + Tramadol
Each tablet contains: Diclofenac 75mg, Tramadol 50mg
1 Tablet
M/s Alembic Ltd.
9.73

Sl.
No
.
Name of the Scheduled
Formulation
Dosage form & Strength
Unit
Ceili ng Price (Rs.)
Review Order
number and
date
Existing SO number and
date
Manufacturer &
Marketing Company
respectively
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
1.
Trypsin, Bromelain, Rutoside Trihydrate, & Diclofenac Sodium (Volitra Enzo) tablet
Each enteric coated tablet contains: Trypsin 48mg, Bromelain 90mg, Rutoside Trihydrate 100mg, Diclofenac Sodium 50mg
1 Tablet
13.91
31015/09/2017 -Pricing dated 27.08.2017
4131(E) dated 22.12.2016(at Sl. No. 5)
M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Sun Pharmaceuticals Ind. Ltd.

Sl.
No.
Name of the Scheduled Formulation
Dosage form &
Strength
Unit
Ceilin
g
Price
(Rs.)
Review Order
number and
date
Existing SO number
and date
(1)
(2)
(3)
(4)
(5)
(6)
(7)
1.
Ceftriaxone
Powder for Injection 1gm
Each
Pack
48.92
31015/59/2017-Pricing dated 10.10.2017
2058(E) dated 30.6.2017 (at Sl. No. 120)
2.
Chloroquine
Tablet 150mg
1 Tablet
0.72
31015/32/2017- Pricing dated 24.8.2017
2059(E) dated 30.6.2017 (at Sl. No. 23)

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