Can we Invest on a Pharma Company? Pharmaceuticals Industry Business Benefits

can-we-invest-on-a-pharma-company-pharmaceuticals-benefits

Can we Invest on a pharma company? Pharmaceuticals Benefits in business: This article is all about  pharmaceuticals as investment options and the benefits of investing in a pharma company rather than any other industries. You can choose between  pharma and biotech depending on your interest exposure and investment  options you have. You can have R&D or F&D, manufacturing , marketing, sales or QA , QC departments.

When you think about the benefits of investing in a pharma company you can hear these two things.

  1. Pharmaceutical companies will always generate profits. I.e benefits
  2. Probability of getting good returns after investing in industry

The first statement is absolutely FALSE. But the second statement is Highly suportable. So now you got what I’m going to talk about this.

Before we approach towards investment perspectives , here are some facts regarding Pharmaceutical industry.

Pharmaceutical Industry Facts

  1. Pharmaceutical Industry size as per WHO – $300 BILLION. that’s why major pharmaceutical industries are called BIG PHARMA .

  2. Over 5000 drugs are under development 70% of these are first line or firsorder which means they can be used for major diseases and disorders.

  3. Indian pharmaceutical industry is growing at CAGR of 14% to 16% per annum.

  4. India is a hub of generic manufacturers and more than 70% of drugs manufactured in India are sent abroad to countries like USA and Azerbaijan as well.

  5. Indian pharmaceutical industry will suffer a decrease of 1% in terms of ROI (return on investment) but it shouldn’t bother first time investors.

Why you should consider pharmaceuticals as investment options?

There are few points you need to know regarding this which are really very crucial to know.

can-we-invest-on-a-pharma-company-pharmaceuticals-benefits
The share price is directly proportional to the industries approvals and development in pharma field .
Eg. The share prices soar if industry wins approval for clinical trials/therapy/drug launch.

The ROI for a person who invested in pfizer (listed in New York stock exchange as PFE) in 2009 and withheld the shares to 2014 got a return of 116%. The scenario isn’t different in India. I don’t have exact figures for Indian company but as its market based you can check any companies figures. You will find them to be great.

Profits- chances of pharmaceutical industry going bankrupt etc is almost impossible. Once a pharmaceutical industry starts failing it is taken over by a giant or Big pharma company so your money may see ups and downs in such case but you will get good returns for sure.

The Net profit of pharmaceutical industries is around 30% to 35% YoY basis. An exception is pfizer that showed a 40% net profit for f.y 2012-13. The profit margins and profits is much more than oil, gas, banks and car makers as well.

 

 Pharmaceutical company capital investment Facts

Do you know how  much capital investment could be typically required for a small sized pharmaceutical company to start with? Let me make you clear about this also to give you a vague idea before you go to your actual research and statistics. Capital investment for pharmaceutical company depends on the size and resources you keep in the pharma company. This cost will include different licences and deposits for the company along with machinery, sale point , godown, transporting van and especially manpower . 

Land in commercial or industry area to set up industry.
Machines or equipments for various departments like QA QC MFG PACKAGING ETC.
man power (skilled) with B.pharm or M.pharma .
Marketing team .

Pharmaceutical industry involves various dependent and independent sections.

Dependent Sections of Pharma Company:

  1. Packaging material
  2. Raw materials
  3. API
  4. Instruments
  5. Apparatus

The industry depends on other industries as mentioned above to prepare its final dosage form.

Independent Sections of Pharma Company:

  1. QA QC
  2. engineering and maintenance
  3. Manufacturing
  4. Marketing

The above mentioned sections work independently but in coordination to run a particular pharma industry. The number of sections may vary .

The reason We need to focus on the nature of work is that it will decide the man power , equipments , technology that you will need in your industry. Let’s consider that you want to open a compressed unit oral dosage form plant i.e. tablet manufacturing unit. This is for tablet unit the cost and will not fluctuate much in case of other dosage forms except parentrals and sera products .

From Indian scinario pharmaceutical industries are typically segmented into two

  1. Manufacturing / + Marketing companies

  2. Marketing only companies

a) Manufacturing / + Marketing companies

Manufacturing co. would need a bit more investment depending on the sections to be started, sections could be Tablets, Capsules, Syrups, Dry Syrups, Ointments, Softgel Capsules etc. You could choose a single section or two to start with gradually adding sections as per the demand of your products in the market.

b) Marketing only companies

If you think that you are good at marketing, you can get your products manufactured from companies already engaged in production. We are one of them. The marketing co. conceives the product and look after the distribution and sales, the production hassles are taken care by the manufacturer, this is termed as Contract Manufacturing. Marketing co. could be started with a small amount starting from few lakh of rupees. Again it all depends how many products you wish to start with.

All of these things will cost you around 2cr INR approximately if you are planning to establish in a region like pune MIDC (out skirts) on a small scale .The cost may be brought down significantly by using varying quality of lab equipment and technology but for a long lasting and fine result generating professional units this is the price approximately. A HPLC unit will cost more than 10lakh INR itself.

Source: Quora-Suraj Thakur & Akshi Talwar

The  fact is that,  first two years will be of real struggle as failure is what you will face but it shall be followed by days of glory.I hope it gives you a reason why you should consider investing in pharmaceutical industry.So, do proper research on your business and also you can take ideas from some experts. Some business companies like Angel Investment Network has achieved higher success with good startups. They are also helping those startup companies find funding and guidance. It can be beneficial for you also to take some ideas about it. Good Luck.

Health ministry to review draft on M Pharm and practice regulation

Health ministry to review draft on M Pharm and practice regulation

In order to set standards in pharmacy education and to bring about an ethics code in pharmacy practice, the health ministry will soon review the draft M Pharm and Pharmacy Practice Regulations framed by the Pharmacy Council of India (PCI).

“The need for an M Pharm regulation has caught the attention of the health ministry considering the challenges pharmacy colleges face in terms of setting quality standards in training. Approval from the government will translate into educational
regulation in post graduate studies with a clear and concrete mandate so that it is properly followed and adhered to by the pharmacy colleges across the country,” PCI president Dr B Suresh said.

“The objective of the M Pharm regulation would be to help the pharmacy institutes address gaps in the delivery of education in a qualitative manner. The regulation once implemented would bring about standards in terms of teacher- student ratio and the infrastructure required.”

M Pharm regulation meant to ensure quality
assurance in post graduate studies will most likely meet stiff resistance from the pharmacy colleges who don’t have funds to meet the requisite standards in terms of staff and infrastructure and hence quality assurance.

Besides this, implementation of the Practice Regulation will benefit the patients in a big way as it will draw an ethics code for the pharmacist to be followed as a part of his/her responsibility to educate patients about the medicines prescribed by the doctor.
The said regulation will bring under its purview all pharmacy professionals working in regulatory bodies, drug stores and academic institutions to cater to patient well being.
In order to further boost the professional development of pharmacists, PCI has also set aside funds for Continuing Education
Programme (CEP) in which an institute or state pharmacy council is entitled to get Rs 25,000 for running the CEP programme having a participation of 100 pharmacists.

These regulations are relevant today going by the upcoming trend of industry driven drug discovery and development. Many of the monographs in pharmacopoeia today for new drugs and devices rely on technology and information from the industry.

Source: CDSCO, New Delhi.

Krokodil – The “Zombie Drug”

krokodil

If you have seen the hindi movie “Go Goa Gone”, you will find this news interesting.  A drug that literally eats a person inside out and makes him look like a zombie has made its way to the markets in the United States. This flesh eating drug is extremely addictive and is named Krokodil. Chemically, it is an opioid (desomorphine), and can be given through the parenteral route. The name “Krokodil” which rhymes with crocodile, is derived from the appearance of a scaly skin, green or black in colour, which is the major side effect of this drug.

The drug causes severe damage to veins and soft tissue infections which is followed by necrosis and gangrene as per the reports published in a study this year.

Five people were hospitalized in Joliet, Illinois and their symptoms closely resembled those of similar cases reported in Arizona and Oklahoma.

Dr.Abhin Singla, an addiction specialist and internist at Joliet’s Presence St. Joseph Medical Center, said that if someone wants a way to die, then Krokodil is one way to do that. It literally eats the patient inside out.

To know more about this drug check out the following links:

Link 1

Link 2

Old Molecule, New Use – Rebamipide

rebamipide

Rebamipide

Rebamipide, which is an amino acid derivative of 2-(1H)-quinolinone, is commonly used for mucosal protection, treatment of gastritis and  healing of gastroduodenal ulcers.

 

In a study published recently, in the Indian Journal of Dermatology, the researchers found that rebamipide can be used as an effective treatment for aphthous ulcers and other realted condtions.

 

MOA: Rebamipide acts by several mechanisms like, causing a reduction in oxygen radicals, increasing the production of protective protagladins and improving blood flow in the mucosa of the ulcer

 

Adverse Reactions of Rebamipide: Rebamipide can cause side effects such as pruritus, nausea, mild to moderate form of skin rashes, constipation and diarrhoea,

 

Precautions: Rebamipide should not be used by the elderly, children and adult patients suffering from chronic illness including cancer. Patients who are hypersensitive to dyes, chemicals and synthetic formulations should not be prescribed Rebamipide.

 

Click here to know more about the findings of the study

Top Selling drugs of 2013

top selling drugs

This article takes a glance at 5 top selling drugs of 2013 in India and the United States. We strongly feel that such questions may be asked in GPAT and NIPER and decided that we must provide our readers with the information of top selling drugs in two of the biggest nations where pharmaceutical products are in huge demand. This list of top selling drugs will also help our readers in gaining information about the companies producing these drugs as we are providing the links to these companies. Moreover, we advise our readers to study the pharmacological profile of these top selling drugs to get thorough knowledge.

Top selling drugs of 2013 – India

Interestingly, the list of top selling drugs in the Indian market does not feature even a single drug from domestic manufacturers. All the five top selling drugs are the once marketed by multi-national companies. This shows the successful marketing strategy employed by the MNCs to gain consumer attention in the Indian drug market.

[table id=5 /]

Top selling drugs of 2013 – U.S.

[table id=4 /]

It is quite evident that there is a stark contrast in the demands of drugs in these two countries. In India, antibiotics and cough suppressants are the top selling drugs whereas in the United States, an antipsychotic and proton pump inhibitors are in huge demand.

MRSA – New study uncovers secrets of antibiotic resistance

Researchers at the Univeristy of Notre Dame, Spain have recently published a study which explains the mechanism of regulation of the critical cell wall cross linking step in the Methicillin Resistant Staphylococcus aureus.
Proceedings of the National Academy of Sciences, the journal which published the results of this study performed by Mayland Chang and Shahriar Mobashery along with their team, has revealed the basis of how the MRSA has evolved into such a dreaded pathogen over the past 50 years when it rapidly spread all over the world. It is noteworthy that the modern strains of MRSA are resistant to antibiotics in a broader sense, including the popularly uses beta-lactams.
In the study, it has been reported that an allosteric portion was discovered in the X-ray structure of the penicillin binding protein 2a of the MRSA bacterium. The penicillin binding protein is the enzyme involved in the cross linking step.
antibiotic resistance pb2

Chang, Mobashery and Juan Hermoso have documented at the CSIC, the Spanish Research Council, that conformational changes are set due to a trigger from an allosteric fragment in the cell wall at a distance of 6 nm. These changes ultimately lead to the opening of the closed active site that enables the catalysis of the physiological function of the enzyme.
The researchers also found that Ceftaroline, a new beta lactam antibiotic which has been approved by the FDA recently, can also bind to the allosteric site and initiate the same response. This is followed by the interaction of another molecule of the antibiotic with the active site of the enzyme which inhibits its function and leads to the death of the bacterial cell. The discovery of this mechanism of action of the new drug is a breakthrough and will help in designing new drugs to tackle the menace of MRSA.
A difficult hospital pathogen to control, MRSA has slowly entered the population in the past few decades, especially in places like nurseries, locker rooms and prisons. It is estimated that in the US almost 20,000 people of the 100,000 affected by this bacterium annually, eventually perish.

FDA Approved and Recalled drugs from May 2011 to Dec 2011

FDA-Approved Drugs in 2011

Cardiology/Vascular Diseases

Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011

Edarbyclor (azilsartanmedoxomilandchlorthalidone); Takeda Pharmaceutical; For the treatment of hypertension, Approved December of 2011

Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting from atrial fibrillation, Approved November 2011

Dermatology/Plastic Surgery

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

laViv (azficelT); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Endocrinology

Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Gastroenterology

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

 

for more click here

[gview file=”https://pharmawiki.in/wp-content/uploads/2012/06/FDA-2011-Newly-approved-drugs-imp-for-niper-2012.pdf”]

Drugs banned in developed world sold in India: Parliamentary Panel -List of Drugs Banned in India PDF

The Parliamentary Standing Committee on Health and Family Welfare also pointed to serious lapses and irregularities on the approvals of new drugs and pointed out that 33 such drugs were approved without conducting clinical trials on Indian patients.

The Committee said scrutiny of 42 drugs picked up randomly involving grant of drug approvals in utter disregard of regulatory procedures and violation of rules and pointed out to files of approval of three controversial drugs (pefloxacin, lomefloxacin and sparfloxacin) found missing and untraceable.

These drugs were either never marketed or withdrawn in the US, Canada, Britain, Australia and other countries.

Citing the example of Deanxit, the Panel pointed out that the drug continued to be prohibited for sale and use in Denmark, the country of its origin, and thus permission to import and market it in India was given unlawfully.The panel cited another example of Letrozole by Novartis, used as an anti-cancer drugs used only in post-menopausal women, is used only in India where it is permitted for use in female infertility.

329 Banned Drugs List in India – PDF Full Download – 2018 – Latest News

List of Drugs Banned in India

A. Single drug preparations (or combinations of)

1. Amidopyrine
2. Phenacetin
3. Nialamide
4. Methaqualone
5. Methapyriline (and its salts)
6. Practolol
7. Penicillin skin/eye ointment
8. Tetracycline/Oxytetracyline/Demeclocycline liquid oral preparations.
9. Chloral hydrate
10. Dover’s powder and Dover’s powder tablets I.P.
11. Chloroform exceeding 0.5% w/w or v/v in pharmaceutical preparations.
12. Mepacrine HCl (Quinacrine and its salts) in any dosage form for use for female sterilization
or contraception.
13. Fenfluramine
14. Dexfenfluramine
15. Terfenadine
16. Astemizole
17. Phenformin
18. Rofecoxib
19. Valdecoxib
20. Rosiglitazone
21. Nimesulide Formulatios In Children Below The Age Of 12 years
22. Cisapride
23. Rimonabant
24. Phenyl Propanolamine
25. Human Placenta Extract in topical application for wound healing and injection for pelvic
inflammatory diseases.
26. Sibutramine
27. R-Sibutramine
28. Gatifloxacin
29. Tegaserod

B. Fixed dose combination with any other drug

1. Corticosteroids with any other drug for internal use.
2. Chloramphenicol with any other drug for internal use.
3. Sodium bromide/chloral hydrate with other drugs.
4. Ergot with any drug except preparations containing ergotamine, caffeine, analgesics,
antihistamines for treatment of migraine.
5. Anabolic steroids with other drugs.
6. Metoclopramide with other drugs (except with aspirin/paracetamol).
7. Pectin and/or kaolin with any drug which is systematically absorbed from g.i. tract, except
for combination of pectin and/or kaolin with drugs not systematically absorbed.
8. Hydroxyquinolines with any other drug except in preparations for external use.
9. Oxyphenbutazone or phenylbutazone with any other drug.
10. Dextropropoxyphene with any other drug except antispasmodics and/or NSAIDs.
11. Analgin (metamizol) with any other drug.

list of drugs banned in India PDF – 2018

C. Fixed dose drug combinations of

1. Penicillins with Sulfonamides.
2. Tetracyclines with Vitamin C
3. Antitubercular drugs with Vitamins (except Isoniazid with Pyridoxine HCl).
4. Vitamins with Analgesics/Antiinflammatory drugs.
5. Vitamins with Tranquillisers.
6. Atropine and Analgesic-antipyretics.
7. Yohimbine and Strychnine with Testosterone and Vitamins.
8. Strychnine and Caffeine in tonics.
9. Iron with Strychnine, Arsenic and Yohimbine.
10. Antihistaminics with Antidiarrhoeals.
11. More than one Antihistamine in the same preparation.
12. Sedatives/Hypnotics/Anxiolytics with Analgesic-antipyretics.
13. H2 receptor antagonists with Antacids (except those combinations approved by Drugs
Controller, India).
14. Anthelmintics (except Piperazine) with a Cathartic/Purgative.
15. Salbutamol (or any other bronchodilator) with centrally acting Antitussive and/or an
Antihistamine.
16. Centrally acting Antitussives with Antihistamines having atropine like activity in
expectorants.
17. Centrally acting Antitussive and/or Antihistamine in preparations for cough associated with
asthma.
18. Laxative and/or antispasmodic drugs in enzyme preparations.
19. Glycerophosphates and/or other phosphates and/or CNS stimulant in liquid oral tonics.
20. Estrogen and Progestin (other than oral contraceptives) containing per tablet Estrogen more
than 50 ug ethinylestradiol (or equivalent) and progestin more than 3 mg of norethisterone
acetate (or equivalent) and, all fixed dose combination injectable preparations containing
synthetic estrogen and progesterone.
21. Ethambutol with Isoniazid, except in the following daily doses:
Isoniazid 200 mg + Ethambutol 600 mg or
Isoniaizd 300 mg + Ethambutol 800 mg
22. Pyrazinamide with other antitubercular drugs, except that which provide the following daily
doses.
Rifampicin 450 to 600 mg
Isoniazid 300 to 400 mg
Pyrazinamide 1000 to 1500 mg
23. Essential oils with Alcohol having percentage higher than 20% proof (except preparations
given in the I.P.).
24. Liquid oral tonic preparations containing alcohol more than 20% proof.
25. Streptomycin with penicillin in parenteral preparation.
26. Antidiarrhoeals containing adsorbants like kaolin, pectin, attapulgite, activated charcoal etc.
27. Antidiarrhoeals containing phthalylsulfathiazole, succinyl sulfathiazole, sulfaguanidine,
neomycin, streptomycin, dihydrostreptomycin.
28. Antidiarrhoeal formulations for pediatric use containing diphenoxylate, loperamide, atropine,
hyoscyamine, halogenated hydroxyquionolines.
29. Antidiarrhoeals with electrolytes.
30. Fixed dose combinations of haemoglobin in any form.
31. Pancreatine or pancrelipase containing amylase, protease and lipase with any other enzyme.
32. Oral rehydration salts other than those conforming to the following parameters:
a) Oral rehydration salts on reconstitution to one litre shall contain: sodium-50 to 90 mM;
total osmolarity-240 to 290 mOsm; dextrose: sodium molar ratio-not less than 1:1 and not
more than 3:1.
b) Cereal based ORS on reconstitution to one litre shall contain: total osmolarity not more
than 2900 mOsm. Precooked rice equivalent to not less than 50 g and not more than 80 g
as total replacement of dextrose.
c) ORS may contain amino acids in addition to ORS conforming to the parameters
specified above and labeled with the indication for “Adult Choleratic Diarrhoea” only.
d) ORS shall not contain mono or polysaccharides or saccharin sweetening agent.
33. A drug, standards of which are prescribed in the 2nd schedule to Drugs and Cosmetics Act
with an Ayurvedic Siddha or Unani drug.
34. Vitamin B1, Vit B6 and Vit B12 for human use.
35. Diazepam with diphenhydramine HCl.
36. Nitrofurantoin with Trimethoprim.
37. Phenobarbitone with any antiasthmatic drug, or with hyoscine and/or Hyoscyamine, or
ergotamine and/or belladonna.
38. Haloperidol with any anticholinergic agent including propantheline Br.
39. Nalidixic acid with any antiamoebic including metronidazole.
40. Loperamide with furazolidone.
41. Cyproheptadine with lysine or peptone.
42. Diazepam and Diphenhyhydramine Hydrochloride.

Low oxygen levels drive cancer growth

f hypoxia, or low oxygen levels in cells, is proven to be a key driver of certain types of cancer, treatment plans for curing the malignant growth can change in significant ways, said Ying Xu, professor of bioinformatics and computational biology at Georgia University’s Franklin College of Arts and Sciences.

The research team analysed samples of messenger RNA data, also called transcriptomic data, from seven different cancer types in a publicly available database.

They found that long-term lack of oxygen in cells may be a key driver of cancer growth, the Journal of Molecular Cell Biology reports.

Previous studies had linked low oxygen levels in cells as a contributing factor in cancer development, but not as the driving force for cancer growth.

High cancer rates worldwide cannot be explained by chance genetic mutations alone, Xu said, according to a Georgia statement.

He added that bioinformatics, which melds biology and computational science, has allowed researchers to see cancer in a new light.

“Cancer drugs try to get to the root, at the molecular level, of a particular mutation, but the cancer often bypasses it,” Xu said.

“So we think that possibly, genetic mutations may not be the main driver of cancer.”

The researchers analysed data downloaded from the Stanford Microarray database via a software programme to detect abnormal gene expression patterns in seven cancers: breast, kidney, liver, lung, ovary, pancreatic and stomach.

Xu relied on the gene HIF1A as a biomarker of the amount of molecular oxygen in a cell. All seven cancers showed increasing amounts of HIF1A, indicating decreasing oxygen levels in the cancer cells.

Low oxygen levels in a cell interrupt the activity of oxidative phosphorylation, a term for the highly efficient way that cells normally use to convert food to energy.

Low oxygen levels engender the process of creating new blood vessels. They provide fresh oxygen, thus improving oxygen levels in the cell and tumour and slowing the cancer growth – but only temporarily.

“When a cancer cell gets more food, it grows; this makes the tumour biomass bigger and even more hypoxic. In turn, the energy-conversion efficiency goes further down, making the cells even hungrier and triggering the cells to get more food from blood circulation, creating a vicious cycle. This could be a key driver of cancer,” Xu said.

FDA issues final rule on sterility testing of biological products

The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products. The action follows a retrospective review of agency regulations to promote improvement and innovation and is in response to Executive Order 13563 that is designed to improve regulation and regulatory review.
The FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.
The amendments to the sterility testing rule will provide manufacturers of biological products the flexibility, as appropriate, to keep pace with technological and scientific advances.

FDA issued a final rule on sterility testing on May 3, 2012, that amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. The rule is in response to President Obama’s Executive Order 13563 which called for improving regulation and regulatory review.

Specifically, the rule revises sterility requirements under Title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 as follows:

  1. “Eliminates specified sterility test methods, culture media formulae (or formulation), and culture media test requirements
  2. Eliminates specified membrane filtration procedure requirements for certain products
  3. Eliminates specified sterility test requirements for most bulk material
  4. Modifies the repeat sterility test requirements, so that repeat tests will occur only once for each lot
  5. Replaces the storage and maintenance requirements for cultures of test organisms used to determine the “growth-promoting qualities” of culture media with validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating microorganisms, and with verification of “growth-promoting properties” or microorganism-detection capabilities of test and test components
  6. Replaces the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested
  7. Replaces the Interpretation of test results section under § 610.12(c) with a requirement that manufacturers establish, implement, and follow written procedures for sterility testing that describe, at a minimum, the test method used, the method of sampling, and the written specifications for acceptance or rejection of each lot
  8. Simplifies and clarifies the Exceptions section under § 610.12(h)
  9. Identifies the Director of CDER as one of the two Center directors authorized to grant an exemption under the exception provision at § 610.12(h)(2). In the proposed rule, the Center for Devices and Radiological Health was erroneously identified in this exception, instead of the Center for Drug Evaluation and Research
  10. Revises the definition of the term “sterility” under § 600.3(q).
  11. Eliminates certain exceptions for allergenic products related to sterility testing under § 680.3(c).”

Companies will not have long to implement the changes as the rule takes effect June 4, 2012. The proposed rule received several comments from industry and the final rule includes the agency’s response to those recommendations. Overall, FDA “recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner,” according to an FDA announcement of the rule. “This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.”

More Info Click Here

 

Source:

http://www.fda.gov/

www.pharmatech.com