Albert David - Placentrex: Current Status & Future Plans

By Swapan Das, Calcutta.

Albert David Ltd., the Rs. 214 crore Kolkata-based pharmaceutical company, a unit of the Kothari group had a press conference in Chennai on June 20, 2011.  Talking to reporters on this occasion Albert David Limited Executive Director K.P. Mundhra spoke about PLACENTREX - their HPE based product’s current status and company’s future plans.

On Company’s flagship product Placentrex:

K.P. Mundhra
ADL- Executive Director

• Production of placentrex injection and placentrex gel has restarted in Kolkata manufacturing plant following a Delhi High Court verdict and the central government lifting the ban on it May 30, 2011. The company challenged the decision in the Delhi High Court where the the government could not prove the reasons for the ban either scientifically or through material evidences.

• Placentrex,is  used to treat pelvic infections in women and heal open wounds, including burn injuries, and there are no safer or efficient alternatives to Placentrex.

• Efforts are being made to register the product in Russia. Currently the drug is exported to South Korea, Myanmar and Syria.

• The company's HPE formulations, Placentrex (gel and injection) is the only human placenta based product in India developed through indigenous research.

• Placentrex is manufactured using Human Placenta Extract (HPE) and has been recommended by more than 30,000 doctors in India over the past 50 years.

• Not a single negative adverse drug reaction or side effect had been noted in the 60 years of use of the injection and 11 years' use of the gel. The placentas are collected from multiple city hospitals in Kolkata, thanks to a special arrangement with the State's Health and Family Welfare Ministry. About 300 placentas are collected every single day, refrigerated, transported to the factory, where they are stored for seven days after which the process of extraction begins.

• During the processing, the product is tested at three stages for harbouring viruses or bacteria. As per the Company, the temperature used as part of their patented process, it is impossible for these organisms to survive. 

• The company had lost Rs.14 crore due to the ban.

On future plans of Albert David Ltd.:

• Albert David is scouting for manufacturing facilities to produce laxatives, vitamin, anti-oxidants and herbal products, which are currently being outsourced.

• The Company is looking to acquire WHO-certified, Current Good Manufacturing Practice-compliant readymade facilities close to their Ghaziabad plant for their brands Evict (laxative), Sioplex (vitamin) and Siooxy (anti-oxidant) and herbal products.

• The company, which makes pharmaceutical formulations, bulk drugs and injections, has three manufacturing plants — in Kolkata (for tablets, ointment and injections), Ghaziabad (for IV fluids) and Mandideep (needles). It plans to move into a new facility in Kolkata and is identifying land. This unit will also house an R&D centre.

• Albert David, which hopes to clock a turnover of Rs 250 crore this year, plans to invest Rs 50 crore in four years – on manufacturing and marketing of new products in the gynaecological and lifestyle diseases segments.

Compiled from: Albert David - Placentrex: Chennai Press Release
Compiled by: Swapan Das
Courtesy: Albert David Ltd. and the press media mentioned in the above link.

Albert David - Placentrex: Chennai Press Release

Swapan Das, Calcutta. 

Congratulations & a Big Thank You to ADL Team from our HPE Blog for fighting back and keeping the HPE flag flying high. The Albert David’s initiative will also boost the supporters of HPE in other countries. Would request this Indian Company to take initiative in creating awareness about the benefits & safety regarding HPE.

THE PRESS RELEASE:

Kolkata-based pharmaceutical company Albert David Ltd., a unit of the Kothari group had a press conference in Chennai on June 20, 2011. Talking to reporters on this occasion Albert David Limited Executive Director K.P. Mundhra said the company challenged the decision in the Delhi High Court where the Union Government could not prove the reasons for the ban either scientifically or through material evidences.

Read more about the press meet at the following links:

Albert David seeks new overseas markets for drug
MSN India
Chennai June 20 (IANS) Kolkata-based Albert David Limited has restarted production of placentrex injection and gel and is looking at new overseas market for ...

Placentrex injection being produced again Chennaionline News
Thanks to the lifting of the ban by the Union Government on the directions of the Delhi High Court, the Kolkata-based Albert David Limited has started ...
news.chennaionline.com/newsitem.aspx?NEWSID...

Drug made from human placenta back in the market
Times of India
The makers of Placentrex, used to treat pelvic infections in women and heal open wounds, including burn injuries, said there were no safer or efficient ...

Ban lifted on human placental drug PLACENTREX.
Health(Y) Destination
Albert David Limited, a Kolkata based drug manufacturing company has resumed its production of its product PLACENTREX extracted from human placenta. ...

Times Chennai Placentrex injection being produced again
Placentrex is manufactured using Human Placenta Extract HPE and has been recommended by more than 30000 doctors in India over the past 50 years Albert David ...
www.timeschennai.com/index.php?mod=article&cat...

Business Line : Companies News : Albert David scouting for ...
Mr Mundhra was in the city to announce that the ban on the company's product ' Placentrex' has been lifted. Placentrex, made from human placental extract, ...
www.thehindubusinessline.com/companies/article2120801.ece

The Hindu: Ban on use of placental extracts and formulations for human use goes

CHENNAI: The Central Government has withdrawn its February 10 ban on the use of human placental extracts and their formulations for human use.


Sify: Albert David seeks new overseas markets for drug
Chennai June 20 (IANS) Kolkata-based Albert David Limited has restarted production of placentrex injection and gel and is looking at new overseas market for the product, a top company official said Monday.

Times Of India (TOI): Drug made from human placenta back in the market

CHENNAI: The union health ministry has lifted a ban, imposed in May on the manufacture, sale and distribution of drugs made from human placenta, following a Delhi high court order. The makers of Placentrex, used to treat pelvic infections in women and heal open wounds, including burn injuries, said there were no safer or efficient alternatives to their product.

Read the full article here-> Times Of India (TOI): Drug made from human placenta back in the market

IBN LIVE - Ban on HPE, Placentrex relaxed by HC: Albert David Limited

Lucknow, Jun 12 (PTI) Albert David Limited today said that ban imposed on human placenta extract (HPE) and its formulations (Placentrex) by the Centre on Feb 10 has been relaxed by it on directives of the Delhi High Court."The manufacturing and marketing of HPE and its formulations has been permitted for topical application for wound healing and injections for pelvic inflammatory disease," Executive Director Albert Davit Limited, KP Mundhra told reporters here.He said that a gazette notification has been issued by the Centre on May 30 in this regard.Stating that HPE is an original research product of Albert David, a Kolkata based pharmaceutical company of Kothari group with over Rs 218 crore turn over, Mundhra said during its presence for more than five decades not even a single case of adverse during reaction or cross infection was reported from anywhere.He said during the course of ban between Feb 10 and May 20 this year the company suffered loss of about Rs 14 crores but denied to file any damage suit for the losses the company had.

Courtesy:IBN LIVE

The Hindu says ‘Ban on drugs from human placental extract relaxed'

The following got published in The Hindu:

(By Staff Reporter Posted: Wed, Jun 08, 2011)

The ban imposed by the Centre on manufacture, sale and distribution of drugs from human placental extract has been relaxed after a Kolkata-based pharmaceutical company took the matter to the Delhi High Court, company executives said here on Tuesday.

The Union Health and Family Welfare Ministry had passed a gazette notification to ban human placental extract and its formulations, among other drugs, on February 10 citing concerns about the safety of the product.

A city-based company, Albert David Ltd., which has been manufacturing drugs based on human placental extract for over five decades, challenged the order and filed a case in the Delhi High Court.

Albert David gets nod for 'placental extracts’ drugs

The following got published in The Financial Express:
(By INDU BHAN Posted: Friday, Jun 03, 2011 at 0225 hrs IST)

Kolkata-based pharma company Albert David has received a shot in the arm following the Delhi High Court asking the Centre to allow use of human placental extracts for its topical application for wound healing and injectibles for pelvic inflammatory diseases. A division bench comprising justices Sanjay Kishen Kaul and Rajiv Shakdher while noting the health ministry’s submissions that the government had accepted the recommendation's of a expert panel to amend its earlier notification, which banned the drug, said that the company “would be able to carry the necessary activities in terms of the notification” (amended).

Read more at The Financial Express
Check Out: 
Human Placental Extract & Its Formulations Returns With A Bang In India!
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Ministry of Health & Welfare releases Gazette Notification for Human Placenta Extract & its Formulations

The Central Government has released Gazette Notification for Human Placenta Extract & its Formulations. This confirms the use and manufacturing of Human Placental Extract for human use in India for:

• Topical application for wound healing, and
• Injection for pelvic inflammatory disease

CLICK HERE for Gazette Notification G.S.R 418(E) dated May 30, 2011

This confirms the efficacy and safety of Indian brand "PLACENTREX" which is based on human placental extract.

Courtesy: Official website of Central Drugs Standard Control Organization (Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India)

Check Out: 

Human Placental Extract & Its Formulations Returns With A Bang In India!

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Human Placental Extract & Its Formulations Returns With A Bang In India!

By Swapan Das, Calcutta

For the supporters of Human Placental Extract & its Formulations in India, the wait is all but over!

Human Placental Extract and its Formulations is back vide the Gazette Notification No. G.S.R. 418(E) dated May 30, 2011 of the Ministry of Health & Family Welfare.

On Friday May 20, 2011, the Delhi High Court on its verdict has given clearance to the manufacturing, sale and distribution of Human Placental Extract and its formulations for human use in India on the basis of the report submitted by the 9-member expert committee on Human Placental Extract and its formulations.

Earlier hearing the petition on April 6 filed by the Kolkata-based pharma manufacturer Albert David Ltd, which is a pioneer in human placental extract therapy in India, the Delhi High court asked the Indian Union Health Ministry to constitute a 9-member expert committee to go into the issue of efficacy and safety data of human placental extract. The expert committee was asked to submit a report on the matter by May 15, 2011. The 9-member expert committee formed by the Union Health Ministry which gave its clearance verdict after doing a thorough review on the issue of efficacy and safety data of human placental extract was consisted of:

• Dr YK Gupta of AIIMS, who headed the panel
• Dr Ajay Kumar of IMA
• Dr Vijay Kumar of IDRI
• Dr Sharma of ICMR
• Dr Kotwal of AIIMS
• Dr VK Tiwari
• Dr B.N. Chakraborty
• Dr CM Sharma
• Dr Lakhbir Dhaliwal of PGI, Chandigarh

Albert David Ltd., India applied the petition against the notification of the Union Health Ministry (GSR 82 E) dated February 10, 2011 in which Union Health Ministry had banned six drugs viz. non-steroid anti-inflammatory drug nimesulide (below 12 years age), gastroprokinetic agent Cisapride, decongestant drug Phenylpropanolamine (PPA), human placental extract & its formulations, Sibutramine & its formulations and R-Sibutramine & its formulations.


And on 30th May 2011, the Central Government has released an amended version vide gazette notification no. G.S.R. 418(E) allowing the use of Human Placental Extract and its formulations.

The rational review of the issue by the 9-member expert committee and Delhi High Court's judgment will boost the ongoing research work on Human Placental Extract in India and the general awareness on this domain which is quite low is expected to increase after this decision.


SUMMARY: Delhi High Court ruling & Central Government (India)'s notification no. G.S.R. 418(E) dated 30th May 2011 means:

• Manufacture, sale and distribution of Human Placental Extract and its formulations is once again allowed in India following the guidelines of the amended notification.

• The use of Indian brand "PLACENTREX" manufactured by Albert David Ltd.  ,Calcutta will continue while complying with the guidelines of the notification.

• CLICK HERE for Gazette Notification G.S.R 418(E) dated May 30, 2011

The Madras High Court has extended an interim stay till June 13, 2011

CIPI's T.S. Jaishankar has informed us that today the Madras High Court has extended an interim stay on the notification of the union health ministry (GSR 82 E) dated February 10, 2011 banning formulations of Nimesulide (below 12 years age) and Phenylpropanolamine (PPA) upto 13 June 2011.

Readers Responses on Dr. K.K. Aggarwal's eMedinewS

Recently Dr. K.K. Aggarwal's eMedinewS has published the letter of Dr. Piyali Datta Chakraborty (who is a part of IICB team working on Human Placental Extract research in India). Dr. R S Bajaj from Delhi as a reader to that post, responded to this on the 27th March 2011 issue of eMediNewS. We wish to share his feedback with our readers, and our sincere courtesy to  Dr. K.K. Aggarwal's eMedinewS for this.

Originally Published at:Dr. K.K. Aggarwal's eMedinewS - 27th March 2011 Edition

IICB take on Safety Aspect of Drug Placentrex

By Swapan Das, Calcutta

The recent approach of Indian drug regulator bodies and Union Ministry of Health towards Human Placental Extract and its formulations has created huge fuss on its use. In India an  aqueous extract of human placenta is sold as drug under the trade name ‘Placentrex’, manufactured by the sole proprietor Albert David Ltd, Kolkata, and are pioneer in India in human placental extract therapy. While Indian   authorities following Western countries and USFDA protocols has raised issues with regards to efficacy and bio-safety of the decades old indigenous human placental extract product “Placentrex”, Japan and Korea seems to be confident on their research and products (“Melsmon”,“Laennec”).
[IMPT: Read more for the letter from Dr. Debasish Bhattacharyya, Scientist-F and Deputy Director of IICB on this issue]

Madras High Court postpones hearing on banned drugs case to April 18, 2011

* LATEST UPDATE: 

 - Check Our LIVE NEWS page

 - The Madras High Court has extended an interim stay till June 13, 2011

Courtsey: Ramesh Shankar, Mumbai, Pharmabiz.com Saturday, April 02, 2011, 08:00 Hrs  [IST]

The Madras High Court has postponed the hearing on the interim stay of the  court dated March 15 in which it had allowed 15 days time to the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA), which were banned in the country on February 10 this year by the union health ministry along with some other drugs. The next hearing on the issue will be held on April 18.

Status of Recently Banned Medicines in India

By Swapan Das, Calcutta

* LATEST UPDATE: 

•  Check Our LIVE NEWS page
•  The Madras High Court has extended an interim stay till June 13, 2011

We have observed that off late, there is a huge surge of visitors to our site and many of them are interested in knowing the latest status of recent banned medicines in India - the courts stay orders, steps taken by regulatory bodies and pharma associations for this. The readers should understand that this site is not a news agency and have certain limitations and sometimes becomes beyond the scope of this site to provide every news related to this.

Fate of indigenous human placental extract

By Swapan Das, Calcutta

What I have personally noted is that there's lack of general awareness regarding human placental extract. Just for the sake - that’s Western countries not using it, so we should also "discard" one of our own products is not done. Today there's country restrictions apply for HPE products but one should analyze under what circumstances they have been enforced while its currently being used in Oriental countries like Japan and South Korea with their Govt. approvals and what could be the consequences of it (esp. in India) if such restrictions are withdrawn in western countries.

Madras High Court stay on immediate withdrawal of - Nimesulide (pediatric) and PPA

* LATEST UPDATE: 

 - Check Our LIVE NEWS page

 - The Madras High Court has extended an interim stay till June 13, 2011

Today's Business Standard has come up with this news of Madras High Court temporary allowing of sale of recently banned drugs - Nimesulide (pediatric) and PPA until March 31, the next date of hearing, which we informed to our readers on March 16 on this issue at: Chennai High Court allows sale of the two banned medicines

You may read today's news on this issue at: Business Standard

[PS: Human Placental Extract being one of the recently banned drugs, I thought many would be following the news related with recent banned drugs in India, and that's the reason to incorporation of this news]


[Check Out: Status of Recently Banned Medicines in India]

* LATEST UPDATE: 

 - Check Our LIVE NEWS page

Chennai High Court allows sale of the two banned medicines

* LATEST UPDATE: 

 - Check Our LIVE NEWS page

 - The Madras High Court has extended an interim stay till June 13, 2011

The Indian pharma companies who have got their medicines recently banned by DTAB and eventually by the Ministry of Health may get some oxygen from the news that on Tuesday (Mar 15, 2011) the Chennai High Court allowed sale of two banned drugs for another four weeks acting on a plea of small pharmaceutical companies so that that the manufacturers can now exhaust those products with their stockists and chemists. 

-- Swapan Das

Application under Section 6 of the Right to Information Act, 2005 - INDIA

The issue of Human Placental Extract has been raised at the Right to Information forum (India), the RTI Community.  The Right to Information has been requested for the following issues, which many in India would vouch for the same. The questions asked are:

FMRAI passes resolution against DCGI's recent decision to ban 4 drugs

* LATEST UPDATE: 

 - Check Our LIVE NEWS page

 - The Madras High Court has extended an interim stay till June 13, 2011

Courtsey: Pharmabiz.com

Peethaambaran Kunnathoor, Chennai

Saturday, February 26, 2011, 08:00 Hrs  [IST]

The Federation of Medical and Sales Representatives Associations of India (FMRAI) has passed a resolution against Drugs Control General of India’s recent decision to ban certain drugs produced and marketed in the country. The Federation passed the resolution in this regard in its general council meeting that held in Kota in Rajasthan last week.

According to FMRAI, the DCGI is deliberately creating ground for MNCs to capture markets for certain segments of drugs which have been in use and in circulation for several years in India.

Recently, the Union health ministry has banned four drugs based on the recommendations by 

Drugs Technical Advisory Board. The unsafe drugs are nimesulide, cisapride, phenylpropanolamine (PPA) and placentrex. FMRAI office-bearers said these drugs have been banned by the ministry without making a proper scientific study on each of the drug.

While quoting placentrex as an example, the office-bearers said it has been manufactured and marketed in India by the Kolkota based company Albert David for more than fifty years. The medicine was available in the form of lotion, gel, and injection and being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc. For conducting surgery, orthopaedic treatments and in gynaecology also this medicine was being used widely.

One medical representative of Albert David said he is marketing this medicine in Tamil Nadu for several years and so far no doctor has suspected its safety  and no adverse effect has been reported. He said the company, which has a turnover of 70-80 crores, has got more than 350 medical representatives and it employs about 750 people in various capacities. The ban of placentrex will make these employees and representatives jobless, he believes.

The resolution of FMRAI says comprehensive and scientific studies should be conducted to ban the use of any drug. It alleges that the present ban on four drugs is because of pressure from vested interests which will adversely affects the nation’s economy and the pharma industry.


[Check Out: Status of Recently Banned Medicines in India]

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 - Check Our LIVE NEWS page

Rethink ban on placenta extract drug, plead docs

Courtsey: | DNA. Sunday; Mumbai, Feb 20, 2011

If you are suffering from 'white patches' on your skin, you will now have to choose an expensive alternative of medicine.

A cheap medicine widely used for white patches and other skin ailments in India was banned for production and marketing and now doctors are writing to the Drug Controller General of India (DCGI) to reconsider it. The medicine is made from the extract from human placenta.

The drugs watchdog had banned human placental extract and its formulation from production and marketing in the country, with four other medicines, including nimusulide for children below 12 years of age.

"Human aqueous placental extract is a very effective drug. We, the team of Indian Institute of Chemical Biology, are working for the past 12 years with the extract. The drug's trade name is 'Placentrex' and has been identified with different molecules with potent therapeutic efficacy. Banning this drug is a huge loss for the people suffering from chronic, non-healing /diabetic wounds, burn injuries and surgical trauma among others," Dr Piyali Datta Chakraborty, in a letter, wrote to the DCGI.

Without knowing its efficacy and safety, banning this reputed product in India is very unethical. Banning of such a globally-accepted drug must be reconsidered, she added.

Recent scientific research has shown mitogenic actions of cytokines from placenta show an array of physiological effects - anti-inflammatory, regulation of autonomous nerve system, improvement of circulation, wound tissue healing, inhibition of protease, enhancement of nerve regeneration, balancing multiple hormone levels, immune boosting (anti-allergic), analgesic effect and the improvement of intestinal environment.

"The cheap medicine is available in cream and gel form. I have not come across any side effect from human placenta extract," Dr Puneet Goyal, a cosmetic dermatologist at Fortis Escort Hospital, said.


[Check Out: Status of Recently Banned Medicines in India]

* LATEST UPDATE: 

 - Check Our LIVE NEWS page