Thousands of FDC drug manufacturers in the country engaged in production of drugs licensed prior to September 21, 1988, can now heave a sigh of relief as the Drugs Controller General of India (DCGI) has excluded such drugs from the requirement of proving the safety and efficacy of FDC drugs licenced by the SLAs without due approval from the DCGI.
On January 15 last year, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and had made it clear that those FDCs approved by the State licencing authorities (SLAs) from October without the permission of the DCGI will be considered for ban.
“An issue has been raised regarding applicability of above requirements for FDCs licensed by State licencing authorities before 21.09.1988, after which all relevant provisions relating to New Drugs were introduced in Drugs and Cosmetics Rules. The matter has been considered by this office and it is hereby clarified that requirements of providing safety and efficacy as mentioned above is not applicable for such FDCs which are licensed prior to 21st September 1988”, DCGI Dr GN Singh clarified in a letter addressed to all the state drug controllers in the country.
The DCGI’s clarification comes at a time when the DCGI’s office is conducting the massive exercise of examining the rationality of thousands of FDCs permitted by the SLAs without due approval from the DCGI.
The union health ministry had earlier constituted expert panels for the exercise of examining and regularising the thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the DCGI. The expert panels have already held three meetings and the fourth meeting is scheduled for June 11.
The Maharashtra Food and Drug Administration (FDA)’s online WHO GMP certificate generation system, introduced by the FDA around two years ago, has now been upgraded through a robust IT backed system to such a level that the FDA is now able to provide the WHO GMP certificate to the exporters in 10 days.
Besides creating an electronic storage of data for easy retrieval at any time, the new online system developed by the FDA ensures avoiding duplication or counterfeiting of the certificates by assigning a software generated unique authorisation code to each certificate. Among the other unique attributes of the system, the SMS delivery system keeps the manufacturers updated when they are offline and authentication of the certificates can be verified by the authorities very easily.
The new system will go a long way in boosting the exports from the state as this new system will help manufacturing units to get WHO GMP certification for exports in 10 days time as compared to three months in the past.
The manual process was time consuming and entailed scrutiny of the application at three levels by the concerned authorities which once approved was sent by post as a Compliance Letter. This system was followed from 2000 to August 14, 2012.
Earlier, joint commissioner (HQ) was designated for signing the various certificates issued under the WHO GMP certificates. Manufacturers from across the state had to come to Mumbai to apply for the certificates and had to submit a sizeable amount of data in the form of papers. The application thus received was cumbersome as it was first received by the drug inspectors at WHO-GMP section and then by the assistant commissioner, WHO- GMP section followed by the final signatures on the certificates by the joint commissioner (HQ).
There are 1703 manufacturing units in the state out of which 247 units are WHO GMP certified. Exports of medicines worth Rs.15,500 crore have been accounted from Maharashtra in the year 2013-14. There are 883 allopathic units, 452 ayurvedic units, 31 homoeopathic units and 337 cosmetic product units across the state.
Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.
Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.
Gene-based and cellular biologics, at the forefront of biomedical research today, may make it possible to treat a variety of medical conditions, including illnesses for which no other treatments are available. Research continues to develop more biologics that will help treat medical conditions or add to existing treatment options.
Here are answers to some frequently asked questions about this diverse and highly important field.
What biological products does FDA regulate?
The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including
- allergenic extracts (e.g. for allergy shots and tests)
- blood and blood components
- gene therapy products
- devices and test kits
- human tissue and cellular products used in transplantation
The Center for Drug Evaluation and Research (CDER) within FDA regulates other categories of biological products mostly produced by biotechnology methods, including:
- monoclonal antibodies designed as targeted therapies in cancer and other diseases
- cytokines (types of proteins involved in immune response)
- growth factors (proteins that affect the growth of a cell)
- enzymes (types of proteins that speed up biochemical reactions), such as thrombolytics (used to dissolve blood clots)
- immunomodulators (agents that affect immune response)
How do biologics differ from conventional drugs?
Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial manufacturing steps.
What is FDA’s role regarding biological products?
FDA’s regulatory authority for the approval of biologics resides in the Public Health Service Act (PHS). However, biologics are also subject to regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because most biological products also meet the definition of “drugs” cited within this Act.
Similarly, some medical devices used to produce biologics are regulated by CBER under the FD&C Act’s Medical Device Amendments of 1976.
- reviews new biological products and new indications and usage for already approved products in order to get biological products on the market for the treatment of known diseases
- helps protect against threats of emerging infectious diseases
- helps provide the public with information to promote the safe and appropriate use of biological products
- conducts inspections of plants that manufacture biologics before product approval is granted, and thereafter, on a regular basis
- monitors the safety of biological products after they are marketed
The PHS Act also
- allows FDA to approve biological products and immediately suspend licenses where there exists a danger to public health
- allows the agency to prepare or procure products in the event of shortages and critical public health needs
- enforces regulations to prevent the introduction or spread of communicable diseases within the country and between states
What are the responsibilities of a licensed biologics manufacturer?
The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are issued by FDA.
Some responsibilities of a licensed biologics manufacturer include
- complying with the appropriate laws and regulations relevant to their biologics license and identifying any changes needed to help ensure product quality
- reporting certain problems to FDA’s Biological Product Deviation Reporting System
- reporting and correcting product problems within established timeframes
- recalling or stopping the manufacture of a product if a significant problem is detected
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Ashland, a specialty ingredients company, has opened a new pharmaceutical centre of excellence in Hyderabad. Spread across 30000 square feet, the unit located in Genome Valley at Alexandria Park, Shamirpet is a state-of-art research facility dedicated for oral solid dosage forms and manufacturing of a line of excipients and a variety of speciality ingredients, tablets and disintegrants needed for the formulation industry.
While talking at the opening of the new centre in Hyderabad, Luis Fernandez-Moreno, president of Ashland Specialty Ingredients, said, “Investment in state-of-the-art facilities allow us to provide growth and deliver innovation where our customers are located. This facility provides our customers in India and throughout the region an excellent research platform that will enhance the needs pharmaceutical formulations industry.”
Initially the new centre employs 20 scientists who will be working on research and development for different product technologies. Currently the centre in Hyderabad is focussed at providing services to both domestic and international pharmaceutical manufacturers. Particularly the centre is expected to cater the needs of markets in South East Asian region.
Ashland’s R&D is dedicated at bringing out optimal yields, as lower variability in oral solid-dosage forms is essential to the future success of the pharmaceutical manufacturing industry. “At our new centre of excellence, we bring together our expertise in process technology and our knowledge in material science to further support the quality, safety and efficiency of oral solid-dosage forms,” said Jim Mish, group vice president, consumer specialities, Ashland.
The company also provides customised training on product applications to the customers. Additionally, its R&D team provides technical assistance for specific requests from customers.
While talking about investments, Nandu Dhekne, vice president, Asia Pacific, Ashland speciality ingredients, said, “We have invested around $10 million in laboratory excellence. Overall about $250 millions have been invested in various units across Asia to gain expertise in pharmaceutical and laboratory care services across the tropical industry”.
With Hyderabad centre, this is the ninth centre of excellence that Ashland specialty ingredients has opened in Asia adding to its global network of three dozen research and development and technical centres.
“Last year the overall revenue of our company was set at $7.8 billion during 2013. This year by September 2014 we are expecting cross the double digit growth,” said Luis, giving the company’s financial details. He said they have pushed in about $ 70 million for the research and development to bring in innovative product technologies in the speciality ingredients segment.
Currently Ashland Specialty ingredients offers industry leading products, technologies and resources for solving formulations and product performance challenges in the key markets including personal care, pharmaceutical, food and beverage, coating and energy, using natural, synthetic and semi synthetic polymers derived from plant and seed extract, cellulose ethers and vinyl pyrrolidones. Overall, Ashland speciality ingredients offer comprehensive and innovative solutions in accordance to consumer demands and industrial applications.
Industry wants health ministry to come out with rejoinder clarification to protect image of Indian generic industry
Concerned over the disturbing media reports published recently, questioning the quality of Indian generic drugs exported worldwide, Indian drug manufacturers across the country have demanded to the Indian government to immediately issue a rejoinder clarification on this matter, clearing the air. The industry fears that failing to take any requisite action, in time, may impact the reputation of the Indian pharma industry as majority of the companies thrive on exports.
Industry insiders pointed out that it has become a hackneyed pattern for the media to keep on attacking the authenticity and reliability of the Indian generic industry, without having any proof of the same, acting on the vested interest of the foreign MNC lobbies. Making matters worse is the lacklustre attitude of the Indian government, which seldom takes up any responsibility to demand clarification on such maligning reports which further thwarts the interests of the industry.
A reliable source from the industry stressed that, it is high time for the health ministry to come out with a rejoinder clarification, elucidating its stand on the issue of quality parameters adopted in the country, to protect the image of Indian generic industry. Many in the industry feels that only a stern intervention from the government will ensure that no one gets a free reign to play with the interest of the Indian pharma industry.
“Ironically such reports are not only a threat to the Indian pharma industry alone, but also an insult to the Indian drug regulators as well. Indian drug regulatory system is one of the strongest in the world and Indian drug manufacturers make sure that we follow all the drug regulations properly. That is why today we are one of the top exporters in the world, then why suddenly should we go on spree to harm the reputation of our industry which we took years to build on,” questioned a disgruntled industry expert.
Dr H G Koshia, commissioner, Food & Drugs Control Administration (FDCA) pointed out that as a regulator he is also concerned by such reports as it may impact the business interest of the Indian manufacturers and the reputation of the Indian regulators, globally. He added, “When such incidence happens in the state of Gujarat, we make it a point to demand clarification from the concerned department on this issue, to ensure that no one is indicted wrongly. Considering that Gujarat is one of the major exporters of pharma products in the country, it is a matter of huge concern for us as well and all steps will be taken by us to ensure that the issues of our manufacturers are well represented at the centre.”