Sunday, 13 January 2019

Sunday, 2 December 2018

       Future of pharma outsourcing

The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate in Japan (2.1%) and North America (1.4%).1 Impending policy changes, promoting the use of generics in these key markets are expected to further dent the top- and bottom-line of global pharma majors. The industry is bracing itself for some fundamental changes in the marketplace and is looking at newer ways to drive growth.
More than that, India has a growing pharmaceutical industry of its own. It is likely to become a competitor of global pharma in some key areas, and a potential partner in others. India has considerable manufacturing expertise; Indian companies are among the world leaders in the production of generics and vaccines. As both of these areas become more important, Indian producers are likely to take a large role on the world stage – and potentially partner with global pharma companies to market their wares outside of India.
The Indian economy is worth about US$1,243 billion and rapidly getting bigger.2 Real GDP growth reached 9% in the year to March 2008.3 The rate of increase has since slowed down due to the global financial crisis; in the year to March 2009, growth eased to 6.7%.4 Even so, most forecasters believe that India will continue to show robust growth over the long-term; a survey of professional forecasters performed for the Reserve Bank of India (RBI) anticipates growth improving to 6% in the year ending March 2010,5 and expects robust growth of 7.8% p.a for the next ten years.6 Previous forecasts such as those of Goldman Sachs suggest that India will be the only emerging economy to maintain such an outstanding pace over the longer term, i.e. to 2050 you can check this in figure shown below
An expanding pharmaceuticals market
India’s pharmaceuticals industry looks set for a solid long-term growth. It already ranks fourteenth in the global league table, with sales of almost
US$19 billion in March 2009.10 However, PwC estimates that it will rise to approximately US$50 billion by 2020 – a 163% in the space of eleven years.11 Indeed, in our report, Pharma 2020: The vision, we anticipate that India will be one of the industry’s top 10 markets by 2020.
The Indian Government’s Department of Pharmaceuticals has also initiated operations for a peoples’ medicines shop, called ‘Jan Aushadhi,’ in various locations. These shops sell generic medicines at much cheaper rates than the price of corresponding branded medicines.18
PwC estimates that India’s 10 largest drug firms spent US$480 million on R&D in 2008. The bulk of this investment went towards developing new formulations, however R&D in the Indian pharmaceuticals industry is changing. The new patent regime means companies need to be more innovative, rather than relying solely on reverse-engineering existing formulations. The reliance on anti-infectives is also likely to lessen. As already noted, as the illnesses of affluence and age increase, the demand for many other types of pharmaceuticals will rise, and Indian pharma companies need to begin transforming their portfolios accordingly.
A number of Indian pharma companies have spun off their R&D divisions into separate units in order to scale up resources and to attract focused investments. DRL started the trend in R&D spin-offs in 2005. Piramal Life Sciences, Piramal Healthcare’s R&D division, was recently demerged from the latter. Sun Pharma Advanced Research and Ranbaxy Life Science Research have also been demerged from their parent companies Sun Pharma and Ranbaxy respectively. Some spin offs have faced difficulties stemming from uncertain resources and declining PE interest in research. Several companies are now seeking a collaborative approach towards drug discovery, in order to mitigate the risk associated with failure of a drug molecule.
The modern process for drug discovery and testing now generates very large quantities of data through computer modeling and simulations, genetic sequencing, and other data-intensive processes. Further, as we noted in Pharma 2020: The vision, pharma companies are under increasing pressure to document the efficacy of their products; tracking patient outcomes represents a further source of large quantities of data. In order to facilitate the storage, management, retrieval and analysis of this large pool of data, a new subsector of the IT sector has emerged – bioinformatics. Tools have been developed which can help lower cost, improve efficiency, and streamline the process of documenting a drug’s efficacy throughout development until launch and beyond.
Global pharma players can take advantage of a variety of options to maximise their investment in India. As many pharma companies turn to more collaborative business models, Indian companies are likely to play an increasingly important partnering role.
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Author = samprgmr

Saturday, 4 August 2018

Pharmaceutical counterfieting
A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/ or source. 
Counterfeiting of medicines can apply to both branded and generic products. Generally, counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with in correct quantities of activities ingredients or with fake packaging
 Counterfeit Medicines

Products marketed with intent to deceive

1– Counterfeit active/bulk ingredients
2– Counterfeit finished products
3– Unregulated diverted products
4– Counterfeit labeling
5– Mislabeled substances (e.g., generic anti-biotics)


Why are Medicines a Target?

  1. Fakes can be made relatively cheaply (at least as profitable as narcotics – lower risk).
  2. Many countries, especially in the developing world lack adequate regulation and enforcement
  3. Even in the industrialized countries, the risk of prosecution and penalties for counterfeiting are inadequate
  4. The way in which medicines reach the consumer is also different from other goods:  the end-user has little knowledge of the product – a ‘credence’ good

What is Particular to  Pharmaceutical Counterfeiting?

  1. Medicine counterfeiting is much more of a threat to public health than to company revenues
  2. Developing countries are the worst affected where regulatory structure is weaker and measurement and oversight is difficult; consumers in LDC’s often buy Rx drugs directly over the counter
  3. Non-branded generics are very widely counterfeited (e.g., ampicillin, paracetamol)
  4. Prices vary widely across the world, and parallel trade is widespread, allowing counterfeit medicines to enter the supply chain
  5. People will not knowingly buy a counterfeit drug, but consumer detection is extremely difficult: price is not an indicator in insured markets    
Current and Future Risks
  1. Treatment failure in malaria, TB and HIV/AIDS
  2. Growth of resistance to existing anti-infectives from use of sub-par treatments
  3. Spread of drug resistant pandemics, including HIV and influenza
  4. Use of illegal funds to finance further illegal manufacture of medicines and even terrorism
  5. Globalization of pharmaceutical production know-how drives counterfeiting: supply-driven
  6. Counterfeit drugs are increasingly showing up in OECD countries

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South Africans need to return 318,000 packets of potentially dangerous pills

The South African distributor of heart pills that may contain a potentially carcinogenic ingredient has confirmed that more than 318,000 packets of pills may be affected.
“Operationally, it is a difficult situation,” a representative of Pharma Dynamics, the distributor of the tablets in South Africa, told Business Insider South Africa.
The South African Health Products Regulatory Authority (SAHPRA) this week recalled Dynaval Co high blood pressure and heart pills, which may contain a controversial carcinogenic ingredient that was manufactured in China.
Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg pills, which were manufactured by Zhejiang Huahai Pharmaceuticals, may contain the chemical NDMA.
NDMA is associated with liver damage and liver cancer in rats as part of laboratory tests, says dr Eric Decloedt, a clinical pharmacologist at the department of medicine of the University of Stellenbosch. “We extrapolate that it could hold the same risks for people.”
The affected pills contain the ingredient valsartan, but only tablets manufactured by Zhejiang may contain the NDMA. Dynaval 80 mg and 160 mg tablets are not affected.
The Dynaval Co pills were not available in the state health sector, but were in wide use among private patients, who used it for high blood pressure,  heart failure and as part of treatment after a heart attack.
According to Nicole Jennings, corporate communications manager of Pharma Dynamics, more than 318,000 packets of the pills are still in circulation. Anyone with a packet of Dynaval Co should urgently return the medicine to their pharmacy.
European authorities first announced a recall of the batch of medicines that was manufactured by Zhejiang earlier this month. It took a full three weeks for the local authorities to order its withdrawal in South Africa. 
"The responsibility of managing this matter and communicating this information to the public is shared by both SAHPRA and the manufacturers," a SAHPRA spokesperson told Business insider.
“Once SAHPRA was informed by Pharma Dynamics about the affected products, appropriate actions were undertaken in consultation with the manufacturer, to warn healthcare professionals and the public about this potential risk.”
She said that to date, SAHPRA has not identified other valsartan containing products that are affected.
At this stage reports around the impurity possibly causing cancer has not been verified by any health authority, said Jennings.  
“No definitive information has been received to indicate an immediate threat to patients as investigations are still underway."
People who have been using the medicine can get a refund from their pharmacies.
A Pharma Dynamics spokesperson warned that it is dangerous to just stop using the medication – they need to speak to a pharmacist or doctor first about a substitution. The company doesn’t have any immediate plans to foot these doctors’ bills, however.
Decloedt says other medicines containing losartan, candesartan or telmisartan – and pills that contain valsartan but not NDMA – could be prescribed.
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Wednesday, 1 August 2018

Regulatory intelligence

Pharma regulatory intelligence

Less complexity. More clarity.

Regulatory intelligence refers to the process of gathering, monitoring and analyzing regulatory information and data to track developments in the changing regulatory environment. Banking, financial services, and insurance sectors continue to experience unprecedented volumes of regulatory change and complexity. Our unique one-stop Regulatory Intelligence provides world-class content and advanced technology that cuts through the complexity and the sheer volume of content and developments within the regulatory compliance environment. That’s how we can provide clarity on what is most important to your organization – in a cost effective way.

Unsurpassed breadth, depth and quality

Regulatory Intelligence includes global coverage of over 900 regulatory bodies and more than 2,500 collections of regulatory and legislative materials. It is powered by exclusive news, analysis, and practical guidance from our global team of regulatory compliance experts and journalists, and it has an intuitive user interface with powerful search functionality and easy navigation. This way, you can access whatever information you need, when you need it, from one single source.

Regulatory Intelligence Feeds incorporates our client-driven taxonomy to automate the flow of regulatory information into your organization. Content is extracted from our regulatory database – the same source that drives our Regulatory Intelligence solution. This allows for a smarter and easier workflow to be created in the application, and by utilizing our data feed in your compliance activities, you can be assured that the business is reviewing and implementing regulatory change as it occurs.

Single information source
A cost-effective and simplified research process, with comprehensive content, intuitive features ,and user-friendly functionality. Focus on anticipating and navigating the regulatory environment, alongside your general day-to-day responsibilities, by taking away the burden of having to manually track and monitor multiple and varied sources of regulatory information.
More focus, less noise
Focus on the information needed to quickly reach informed and targeted decisions. Keep track of regulatory developments that specifically impact your organization through powerful features to search, filter, and automatically monitor the relevant developments.
Trusted and reliable
Our trusted global regulatory experts and editorial team, who analyze news and events on a daily basis, provide analysis and practical guidance. They provide hot topics and news and impact analysis of current and forthcoming regulations. The breadth and depth of the knowledge and expertise that goes into the collection and analysis of regulatory developments means that you consistently have access to the most thorough, accurate, and reliable regulatory information available.
Manage regulatory risk
With the shift towards bigger fines and greater personal liability, the need for organizations and compliance professionals to stay compliant has never been greater. Regulatory Intelligence reduces the potential room for errors and vulnerability within your organization by providing information that has been stringently tracked, monitored, and analyzed. Content is structured and maintained to ensure you have the most up-to-date information at all times to manage and mitigate risk.
Practical and actionable information
Thomson Reuters Regulatory Intelligence gives constant access to practical advice, best practice materials, and knowledge to implement relevant regulatory changes within your organization, and to make sure organizational structures are aligned to current and upcoming regulations. Information and reports can be created and customized for valuable and meaningful board level reporting and shared within the organization.
Concise information for a focused view
Content within Regulatory Intelligence has been configured to ensure you can easily find the relevant information to get clarity on what is most important to your organization. This simplifies the research process, as you do not have to spend time sifting through vast amounts of irrelevant information.
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Monday, 23 July 2018



Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission.
Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations.

Medical and Clinical Consulting
Consulting on the Complete Product Development Program (all phases)
Reviewing and Assessing Clinical Protocols
Reviewing Safety and Efficacy Related Issues During Product Development
Adjudicating Clinical Data
Worldwide Drug Safety and Pharmacovigilance Services
Clinical Trial Safety Services
Post-Marketing Surveillance Services
Pharmacovigilance Consulting Services
EudraVigilance Reporting
Regulatory Support of New Chemical Entities
Global Regulatory Strategies
Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)
CMC (Chemistry, Manufacturing, Control)
Medical Writing
Translations of Technical Documents
Coordination of Regulatory Certificates
In-licensing of Products for Marketing in the Emerging Markets
Assessment of Local Medical Need
Assessment of the Local Business Opportunity
Assessment of the Appropriateness of the Existing Documentation for an Approval in the Target Countries
Potential in-licensing of the Product
Serve as the Local Marketing Authorization Holder
Sales, Marketing, and Distribution Performed by a Local Distributor
Postmarketing Regulatory Maintenance
Regulatory Maintenance of Marketed Products
Life Cycle Management of Recently Marketed Products
Regulatory Maintenance of Older Products
CMC (Chemistry, Manufacturing, Control)
Post-Marketing Drug Safety & Pharmacovigilance
Labeling Updates and Harmonization of Labels
Product Transfers
Product Acquisitions (regulatory due diligence)
Company Mergers
Company Acquisitions (regulatory due diligence)
Regional Marketing Deals (co-promotion, co-marketing)
Coordination of Regulatory Certificates
Special Projects
Educational Activities
Training of personnel in pharmaceutical companies
Training of regulatory agency personnel from the emerging markets
Organizing meetings with drug development topics
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Tuesday, 17 July 2018

GDP(Good Documentation Practices)

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

What to write, and how to
GDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.

GDP / GDocP standards

Documentation creation

  • Contemporaneous with the event they describe
  • Not handwritten (except for handwritten entries thereon)
  • When electronically produced, the documentation must be checked for accuracy
  • Free from errors
  • For some types of data, it is recommended that records are in a format that permits trend evaluation

Document approval

  • Approved, signed, and dated by appropriate authorized personnel

Handwritten entries

  • Adequate space is provided for expected handwritten entries
  • Handwritten entries are in indelible ink
  • Errors (i.e. misspelling, illegible entries, etc.) are corrected and reason is documented
  • Critical entries must be independently checked (SPV, or second person verified)
  • No spaces for handwritten entries are left blank - if unused, they are crossed out or "N/A" (or similar text) entered
  • Ditto marks or continuation lines are not acceptable
  • A stamp in lieu of a handwritten signature is not acceptable

Copies of documents

  • Clear, legible
  • Errors are not introduced

Document maintenance

  • Regularly reviewed and kept current
  • Retained and available for appropriate duration
  • Electronic document management systems are validated
  • Electronic records are backed up

Document modification

  • Handwritten modifications are signed and dated
  • Altered text is not obscured (e.g., no correction fluid)
  • Where appropriate, the reason for alteration must be noted
  • Controls exist to prevent the inadvertent use of superseded documents
  • Electronic versions can only be modified by authorized personnel
  • Access to electronic versions must be controlled by password or other means
  • A history (audit trail) must be maintained of changes and deletions to electronic versions
  • Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)

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Saturday, 14 July 2018


Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

All guideline follows a few basic principles:
  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
  • Operators must be trained to carry out and document procedures.
  • Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
  • Any distribution of products must minimize any risk to their quality.
  • A system must be in place for recalling any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
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Tuesday, 26 June 2018

Regulatory Affairs

Regulatory affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticalsmedical devicesbiologics and functional foods).
Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:
·         Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
·         Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
·         Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance
Healthcare RA
The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
·         pharmaceuticals
·         medical devices
·         in vitro diagnostics
·         biologics and biotechnology
·         nutritional products
·         cosmetics
·         veterinary products

The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.
Core competencies
Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor's degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.
Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products. Global aspects of regulatory affairs are taken up by organisations such as the Drug Information Association (DIA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The healthcare industries were the first to be significantly regulated in the modern era. Much of this regulation has stemmed from avoiding the repetition of disasters, and has tended to be led by the USA due to size of the market and its technological lead
·         Diphtheria Epidemic led to 1902 Biologics Control Act
·         Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
·         Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
·         Thalidomide led to the 1962 Kefauver Harris Amendments
·         Dalkon Shield led to the 1976 Medical Device Amendments
·         Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act
In the USA, this regulation is largely written directly into law and codified in Title 21 of the Code of Federal Regulations
Recent developments
Starting in 1980 the European Union started to harmonize the regulation of healthcare products in the member states. The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device regulation. Concurrently the EU had been developing the concept of New Approach Directives where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able).
The Europeans took the radical approach of applying the New Approach Directive to Medical Devices and by doing so made the first significant conceptual advance in healthcare regulation for nearly 100 years.
The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the international template
Future developments
Many in the Regulatory Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety.
Regulatory Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or outtask regulatory affairs to external service providers. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review.
Regulatory affairs profession
The (healthcare) regulatory affairs profession is still an emergent profession but has four major international professional membership organizations:
·         Drug Information Association, DIA, link 
·         The Regulatory Affairs Professionals Society, RAPS, link
·         The Organisation for Professionals in Regulatory Affairs, TOPRA,link
·         Association of Regulatory Affairs Professionals,ARAP India, link
·         Vietnam Regulatory Affairs Society: link
which offer education and training, professional development, competence certification and codes of ethics.
The regulatory professional typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.