Gujarat FDCA raids 50 chemist shops selling spurious antibiotics in Ahmedabad

Shardul Nautiyal, Mumbai Tuesday, January 10, 2017, 08:00 Hrs  [IST]

As a part of its ongoing crackdown on spurious drug racket spread across Delhi, Karnataka, Tamil Nadu, Gujarat and Maharashtra, Gujarat Food and Drug Administration (FDCA) has detected 50 drug retail stores in Ahmedabad which were supplied fake/ spurious drugs by a drug dealer based in Delhi. These spurious drugs were marketed under the names of fictitious companies, as per the investigations taken up by all the state drug controllers where the racket has been detected. Practicing doctors were found prescribing spurious antibiotics kept in these retail drug stores. The modus operandi of the drug dealer was such that invoices were raised by licensed wholesalers and supplied to retailers and doctors with a huge margin the cost of which was passed on to the gullible patients. Madhya Pradesh state drug regulator informed that the products were supplied through a Delhi based trader - Shakti Traders with invoice being raised by a drug wholesaler in Gwalior. Meanwhile, Gujarat FDCA has filed FIRs and canceled licenses of two Ahmedabad based wholesalers SR Enterprises and Shraddha Healthcare for marketing spurious drugs as a part of their involvement in the inter-state drug racket subsequent to state regulator’s seizure of antibiotics worth over Rs. 51 Lakh in Ahmedabad recently led by Commissioner FDCA Dr H G Koshia. Vadodara based drug testing lab in its test report concluded that antibiotics were grossly spurious with no active ingredients. Dr Koshia has remarked that a racket of this magnitude has been detected for the first time in Gujarat and the state regulator is in constant touch with drug controllers of other states to nab the master mind of the racket. Based on a tip-off that these drugs have been supplied in a clandestine manner to Ahmedabad and other areas, Gujarat FDCA officials laid a trap and detected 8 products giving negative results by using hand held infra-red machine and Raman spectroscopy machine. The seized products claimed to be antibiotics like cefixime, azithromycin and ofloxacin were priced at over Rs. 200 for each strip of 10 tablets. A similar kind of racket spanning across Gujarat and Delhi was also unearthed by Maharashtra FDA team two years ago. Over 400 strips of non-surgical abortion medication worth over Rs. 3 lakh were confiscated during the raid from a Mumbai based dealer and two medical representatives who supplied him the pills. The accused were found contravening the provisions of the law under different sections of Essential Commodities (EC) Act and Drugs and Cosmetics Act (D&C Act).

DCGI to set up registry of legitimate online pharmacies to ensure compliance of norms and patient safety

http://www.pharmabiz.com/NewsDetails.aspx?aid=99680&sid=1

Shardul Nautiyal, Mumbai Monday, January 09, 2017, 08:00 Hrs  [IST]

The Drug Controller General of India (DCGI) is currently reviewing a study that would allow optimum use of innovation and technology in online pharmacy by preparing a registry of legitimate online players following which the system of online pharmacy will be governed under a centralised portal as per the provisions of the law. Online pharmacy is currently governed by Information Technology Act, 2000 and Drugs and Cosmetics Act, 1940.   Dr G N Singh, DCGI, says, “To help old patients and who lack access to offline pharmacies, the centralised portal with a registry of legitimate players in online pharmacy is the need of the hour.  We have considered putting in place such a system which could use technology in the interest of patient safety considering the current scenario.” The Indian Internet Pharmacy Association (IIPA) had also in the past urged the sub-committee on e-pharmacy formed by the DCGI under the chairmanship of Maharashtra Food and Drug Administration (FDA) Commissioner Dr Harshdeep Kamble to help set up a registry of online pharmacies to ensure clarity on the legitimate players and frame interim guidelines. In most countries, the legitimate players are given specific operating licenses that are shared with consumers to fight the menace of cross border internet pharmacies. IIPA had also recommended a similar model for India, and also a crackdown on all illegitimate players, online and offline. Meanwhile, DCGI has directed all the state drug regulators to keep a tab on online pharmacies selling prescription drugs until the guidelines on the same are framed. All the state/UT drugs controllers have been directed to keep a strict watch on online sale of drugs and take action if there is  violation of the Drugs and Cosmetics Act and Rules thereunder. IIPA is a group of online pharmacies represented by 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com, SaveOnMedicals and Savemymeds. IIPA has pinpointed that there are multiple online pharmacies operating from different parts of the world that need to be monitored. This according to them will enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

Hindustan Times Reports

http://www.pharmabiz.com/NewsDetails.aspx?aid=99603&sid=1

Gujarat FDCA to cancel licenses of 2 stockists for running inter-state spurious drug racket

Shardul Nautiyal, Mumbai Wednesday, January 04, 2017, 08:00 Hrs  [IST]

Gujarat Food and Drug Administration (FDCA) is planning to cancel licenses of two Ahmedabad based wholesalers SR Enterprises and Shraddha Healthcare for marketing spurious drugs as a part of huge inter-state drug racket spanning Delhi, Karnataka, Tamil Nadu and Maharashtra following state regulator’s seizure of antibiotics worth over Rs. 51 Lakh in Ahmedabad alone. At the time of seizure, FIRs were filed against two Ahmedabad based wholesalers on December 20 as a part of the crackdown led by Commissioner FDCA Dr H G Koshia. Dr H G Koshia explained, “Baroda based drug testing lab has come out with results that antibiotics were grossly spurious with no active ingredients. Following this the Madhya Pradesh state drug regulator informed that the products were supplied through a Delhi based trader - Shakti Traders with invoice being raised by a drug dealer in Gwalior.” He added that a racket of this magnitude has been detected for the first time in Gujarat and the state regulator is in constant touch with drug controllers of other states to nab the master mind of the racket and follow other vital leads in the case. Based on a tip-off that these drugs have been supplied in a clandestine manner to Ahmedabad and other areas, Gujarat FDCA officials laid a trap and detected 8 products giving negative results through hand held near infra-red machine and Raman spectroscopy machine. The seized products claimed to be antibiotics like cefixime, azithromycin and ofloxacin were priced at over Rs. 200 for each strip of 10 tablets. A similar kind of racket spanning across Gujarat and Delhi was also unearthed by Maharashtra FDA team two years ago. Drugs worth over Rs. 3 lakh were confiscated during the raid. The accused were found contravening the provisions of the law under different sections of Essential Commodities (EC) Act and Drugs and Cosmetics Act (D&C Act). According to official sources, Maharashtra FDA officials laid trap on the three accused people engaged in procuring and peddling the pills in Mumbai on a tip off. The racket was run by a licenced stockist based in Mumbai. Over 400 strips of non-surgical abortion medication were confiscated from the Mumbai based dealer and two medical representatives who supplied him the pills. Mumbai based stockist had been violating the law of the land by illegally procuring, stocking and selling the drug to unauthorised people.

Traditional delicacies of Uttarakhand and its future

Traditional delicacies of Uttarakhand and its future

Friday, 16 August, 2013, 08 : 00 AM [IST]

Shardul Nautiyal

Despite the fact that Uttarakhand faced one of the worst natural calamities in the recent past, the hill economy boasts of a rich and delectable legacy ranging from sweets, natural edible oil traditionally extracted from trees and even medicinal juices extracted from flower borne shrubs like Rhododendron which reflects the hill state's rich biodiversity and culture. Singori/ Ball Mithai Primarily engaged in herd rearing, milch animals were the backbone of the hill economy. In due course, lush green forests also became an integral part of the economy with agriculture in the latter stages of evolution which paved way to traditional delicacies. Dairy products probably catered to the basic need of primary settlers of hills and other rural areas since time immemorial. Singori or Patvida Mithai came into being by blending concentrated milk and sugar wrapped with Malu Patta (Bauhinia Leaf), also called as "Ball Mithai.” Ball Mithai (Balled Chocolate) famous in Almora and Champawat is consumed as a dessert which can further be seasoned with sugar balls to make it more delectable. Its same version known as Singori is famous in Tehri Garhwal. Both have a shelf life of minimum 15 days to 30 days under cool temperature. Whereas Singori can easily be distinguished from other traditional sweets by virtue of its herbal packaging, Ball Mithai bears the unique distinction of a local sweet as well with a hard form and texture. It is made by processing milk at higher temperatures for a longer duration to dehydrate it. Its exclusive chocolate and crispy taste makes it a gift item for foodies, tourists and pilgrims. The attractive and durable packing further renders these sweets exclusivity and thus has become a part and parcel of the global journey towards local gastronomy. Rhododendron juice or Rhodo-Squash Burans is a broad leaved evergreen tree found in temperate zone ranging from 5,000 feet to 10,000 feet altitude in the hill state. Burans has been accorded the status of a state tree. Though, there are many species of Burans botanically known as Rhododendron, only five species are found in Uttarakhand. Some species of medicinal value are dwarf and shrubby generally found above 10,000 feet altitude having purple, white, pink and violet flowers. The economic value was attained by Rhododendron arboratum which blossoms with shining red colours on the onset of spring from February onwards and lasts up to May and June based on the altitudes. Though the trunk of mature Burans tree was of commercial importance in the earlier days when it was used to make cooperages i.e. large to small size wooden pots for storing liquid and solid products, the flowers of Burans, (Rhododendron arboratum) gained its economic importance within the last 20 to 25 years by the name Burans Juice or Rhodo-Squash. The process of manufacturing juice starts with the plucking of fresh flowers by rural folk especially women. After removing the anthers, the flowers are washed, cleaned and boiled in hot water to be smashed and filtered. Sugar is then mixed along with some preservatives and the juice gets bottled under hygienic conditions. Some individuals, micro enterprises and local NGOs sell it as a branded juice under FPO licence. Considered to be highly beneficial for heart ailments and stomach disorders, Burans squash is now a popular drink among tourists. Almost all hill districts produce Burans squash up to 5 lakh litre annually which is projected to go up to 50 lakh litres in the coming years by regenerating old Burans stumps and replanting of Burans saplings on a large scale by the initiative of the state government. Burans squash may be supplemented with Rose squash because of its flowering from the second year onwards and a long spell of blooming from March to June in the hills. The Indian Butter Tree The Indian Butter Tree commonly known as Chyur, Chyura or Chyuri is botanically known as Aisendra butyracea, Diploknema butyracea and Madhuka butyracea. This tree is found along the sub-Himalayan tract ranging from an altitude of 1000 meter to 1500 meter in mixed forests. This is a large size evergreen broad leaved tree of Mahua (Basia) group which grows on sloppy, boulder soil and warm climate but as of today is restricted to certain pockets of Almora, Nainital, Pithoragarh and Champawat districts in Uttarakhand. In addition, it is found in forests and agricultural wastelands of Nepal, Sikkim, Bhutan and has been also reported in Andaman & Nicobar islands. Leaves of Chyur are used as fodder, stem as timber, branches/twigs as fuel wood and bark as medicine, flowers yield honey and seeds are crushed to extract edible oil which has the unique attribute to solidify as ghee (Butter) at normal temperature. The tree is therefore also known as 'Kalpataru' due to its versatile attributes. The most important part of the tree is the seed whose kernels contain 70 % oil/fat and is locally known as 'Phulwara Butter’. It is of great commercial value. The edible oil extracted from the seed has the consistency of ghee at normal temperature. Its attributes correspond to that of 'Cocoa Butter' and is also considered to be a substitute for manufacturing chocolate if made available in adequate quantity. Ointment prepared from it is said to be useful in rheumatic arthritis and has proved to be an effective lotion for sole cracks. Thus the Indian Butter Tree has a very high potential for cosmetic and pharmaceutical industry as well. Though adequate literature is available pertaining to the tree, its distribution is restricted to certain localities. It has also been reported as an extinct species in scientific literature. Considering the fact that India imports edible oil and Uttarakhand has favourable climatic conditions with adequate wastelands, Indian Butter Tree can be adopted under large -scale afforestation programmes to gain self sufficiency in natural edible oil. Economics of Indian Butter Tree Assuming one quintal of seeds per mature tree and planting of 20,000 trees annually in 10 hill districts for 10 years, this will translate into one lakh trees in the near future giving yield of one lakh quintals of seeds annually in the 15th year of plantation. Assuming 60, 000 quintals of oil extraction, the present value of oil will be Rs 600 million @ Rs 100 per kg. The future market value can roughly be estimated at Rs 6000 million with price escalation in the near future. If comparisons are drawn with coconut or palm oil, the practice of generating perennial sources of 'Tree Borne Oil Seeds' instead of annual crops of oil seeds can be carried forward practically keeping in mind the reality that adequate agricultural land is not available in Uttarakhand. (Excerpts from the upcoming book “Chronicling Uttarakhand Art and Culture” authored by Shardul Nautiyal)

http://www.fnbnews.com/FB-Specials/Traditional-delicacies-of-Uttarakhand-and-its-future

Red Ink Certificate of Recognition as part of Red Ink Award -2015 instituted by Mumbai Press Club www.pharmabiz.com/NewsDetails.aspx?aid=83063&sid=1

Indian cos gearing up to embrace global GMP norms

Shardul Nautiyal, Mumbai Thursday, March 13, 2014, 08:00 Hrs  [IST]

In the wake of a spate of warning letters on Indian pharma companies by US FDA, the US-based online compliance and regulatory learning solutions company Underwriters Laboratories (UL) Eduneering, which trains drug regulators to ensure safety of FDA related pharma products is planning to equip leading Indian pharma companies on maximizing compliances related to consent decree, Form 483, data integrity and quality management systems. This would entail maintenance of electronic records for inspection readiness of Indian companies. This comes as a welcome change as US FDA commissioner Margaret Hamburg plans to hold multi-year capacity building workshops for domestic regulators to understand US FDA standardised processes of GMPs and cGMPs in drugs and medical devices segment. The workshops are planned to be held in Ahmedabad, Gujarat, Hyderabad, Chandigarh and Goa. FDA Commissioner had made a visit to India between February 10 and 18 for strengthening cooperation between the two countries on regulatory compliances. Informs Dr Kavita Mehrotra, global strategic alliances head, UL EduNeering, "Considering the fact that certain Indian companies have got critical global attention due to certain evasions, violations and avoidances during US FDA inspections, compliance is required for development of closed systems which captures electronic signatures, audit trails and any changes made in the system or content and also simultaneously offer, track, record and report at the same time. This is in accordance to 21 CFR Chapter 11 compliance of US FDA guidelines." To serve compliance and regulatory needs of the fast growing life science community in India, UL and US FDA have also extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending the agreement till 2019. US FDA’s CRADA with UL is the only learning technology agreement of its kind between US FDA and a private sector company. The extended CRADA agreement between US FDA and UL is designed to address training needs that include topics related to international inspections, import and export of products that fall under US FDA purview and intra agency and intra government co-operative agreements. It also involves access to the FDA’s Office of Regulatory Affairs online curriculum via ComplianceWire, which is UL EduNeering’s cloud-based learning platform. Designed specifically for Indian life science industry, the Learning Management System (LMS) called ComplianceWire is built on a cloud- based model which helps reduce IT and validation costs. Capable to cater globally in 34 languages, the system helps in audit readiness for training records while being fully secure and complies with US FDA’s electronic signature governance requirements. Equipped to provide SOP management, it adapts well to the strategic agility of the growing business needs of organizations. UL has trained over 30,000 US FDA inspectors till date. "As a statistical testament to our product leadership in this area, in 2013, we recorded 23 million training completions by our global audience, with 400 clients in pharma and medical device area and government agencies," Dr Mehrotra adds. With the coming of Obama Care and exports of generics, Active Pharmaceutical Ingredients (APIs) and finished drug products from India to the US projected to grow by 40 per cent, Indian life science companies are in dire need of achieving regulatory compliance to minimize organizational risk and improve quality and business performance through training on GMP compliance. Quality culture for patient safety The USFDA Commissioner, Dr Margaret Hamburg in her talks with Indian regulatory experts have advocated the need for a quality culture to be developed in Indian pharma companies. Ellen Leinfuss, senior VP, UL EduNeering and an expert on global regulatory compliance echoed sentiments of Dr Margaret and said that quality is linked to product safety and without focus on quality, the potential for patient harm increases significantly. In an email interview with Chronicle Pharmabiz, Dr Margaret said, "I am pleased that, as a global leader in the pharmaceutical sector, India will continue partnering with us to ensure that the companies exporting products to the US are adhering to established quality standards. On the home front, we at the FDA will also continue to increase our focus on quality. One way we are doing this is through the creation of a new office of pharmaceutical quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the life cycle of a pharmaceutical product." Quips Leinfuss, "As the practice leader for UL EduNeering’s life science business, commitment of the US and India's pharmaceutical community is encouraging as it will help pharma companies foster a “quality culture.” Dr Hamburg stated, “In my talks with regulators and companies here in India, I have placed a great deal of emphasis on why quality matters.” Elaborating on the quality aspect, Leinfuss further says that the work done by compliance and regulatory learning solutions companies with the US FDA over the past 14 years can help develop training and educational programmes around cGMP and other key quality topics for safe delivery of drugs to global patients. Echoing his views Scott Barnard, quality, compliance and learning expert says, "Considering the demand and importance of meeting the quality and compliance expectations of the FDA, my experience of working with life science clients says that development of quality and compliance culture comes from education and training. We have had tremendous success helping clients use cGMP training and systems to build a strong quality foundation for their organizations." Reiterating the point that India pharma industry need to reclaim its position in a global market, Dr Kavita Mehrotra, global strategic alliances head, UL EduNeering concludes, "It is clear that India, the second largest exporter of over the counter and prescription drugs to the US is in the news because it is important to the global market." Proposal to reduce generic drug user fee In order to reduce the financial burden of around 300 US FDA approved pharma facilities in India, Indian Drug Manufacturers Association (IDMA) has asked the USFDA to reduce the annual fee on approved Indian pharma facilities by 50 per cent. This request was made during the discussions between the DCGI and the US FDA Commissioner during her recent visit to India. A proposal which is in the draft stage will be sent to the US FDA by IDMA following the request. The fee to be charged on an annual basis came into effect from October 2, 2012 under the Generic Drug User Fee Amendments (GDUFA). The US regulations require the exporting drug companies to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Says S V Veerramani, president, IDMA, "We would be making a proposal to the US FDA following this request shortly which also aims at offering participation to around 100 small bulk drug companies who are planning to make an entry in the US market. The introduction of a facility fee of $230,000 annually for a US approved Indian facility in formulations and $60,000 for a bulk drug facility which did not exist earlier can be a deterrent for companies looking at regulated markets." Filing for an Abbreviated New Drug Application (ANDA) costs around $50,000 and a DMF Dossier costs $32,000, he further added. As per US FDA, these fees help it to reduce the backlog of pending applications, cut the average time required to review generic drug applications for safety and improve risk based inspections. With a spike in the frequency of US FDA's regulatory action and India accounting for 40 per cent exports of generics to the US, Indian life science companies are in dire need to achieve regulatory compliance through training on GMP compliance, consent decree, Form 483, data integrity and quality management systems. This would also entail maintenance of electronic records for inspection readiness and lead to additional costs in the form of training. "We are also planning to seek a role in offering our services and support to US FDA and Indian pharma companies on conducting mock audits and training workshops for audit preparedness of Indian facilities. We are awaiting a response on this subject from the US FDA," concludes Veerramani. Electronic data management In order to sensitise Indian companies regarding falsified, non existent or destroyed records which leads to violation of GMPs, regulatory experts recommend the need for developing and maintaining electronic data as paper records can easily be lost, damaged or cannot be validated for accuracy. As per the US FDA guidelines, effective documentation procedures must ensure not only the quality of the recorded data but also security of the records and the validity of the signature (electronic records must comply with 21 CFR Part 11). Pinpoints compliance and regulatory expert Scott Bernard, “The paper based records poses several risks in audit accuracy and also raises issues of security and validation.” According to experts, this has become more imperative with the implementation of new laws including the US Food and Drug Administration Safety and Innovation Act (FDASIA). Says S M Mudda, executive director, Micro Labs, “Dr Reddy’s have already started some electronic documentation in modular and phased manner. Micro Labs is also moving towards the same process with the introduction of an automated warehouse management system.” Taking note of compliance and scalability issue, many Indian companies, as well as global multinationals such as Teva Pharmaceutical Industries, Johnson & Johnson, are interested to move from manual system to an electronic system. Says Ellen Leinfuss, SVP, UL EduNeering, an online global regulatory learning solution provider, “We started the process of educating companies about electronic documentation a few months back and six to eight Indian companies have shown interest so far with us." The curriculum and the FDA authored suite of courses on GMP, cGMP, GCP and QSR, offered by UL EduNeeering, is designed to address training needs through services in India and include immediate and long- term relevant topics related to international inspections, import and export of products and global compliance etiquette. Sharing her views on electronic documentation, regulatory expert Dr Kavita Mehrotra explains, “I have had a chance to meet with several heads and leaders of large and mid-size Indian pharma companies in the past couple of months. Most Indian companies are struggling to understand the specifics of global compliance expectations, ranging from the need for appropriate documentation, to electronic records, to visibility and empowerment of QA groups.” Online regulatory and compliance solution is one very reachable way of offering consistent articulate electronically available training to all the employees regardless of their geographical location. Expertize on GMP norms and its accessibility comes as a much needed wake up call to the Indian pharma industry, which is ripe for standardizing training channels to meet the expected global standards. Dr Mehrotra concludes, "Global GMP processes are not only feasible and time tested but are also custom made to suit Indian pharma regulatory environment. There is a need to offer the Indian pharma companies effective, actionable training strategies, tools and content, to demonstrate and observe regulatory compliance.”

Dissolution testing gains ground in Indian pharma industry with new advancements

Shardul Nautiyal, Mumbai Friday, May 09, 2014, 08:00 Hrs  [IST]

In order to highlight the importance of dissolution testing in pharmaceutical industry as a tool in drug development and quality control, Society for Pharmaceutical Dissolution Science (SPDS) conducted its 2nd annual international convention DISSO ASIA 2014 between May 5th and 6th 2014 in Mumbai. Dissolution testing is required for all solid oral pharmacopoeial dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect.  Disintegration was originally thought to be this characteristic. The United States Pharmacopeia (USP) introduced its disintegration test in 1950. With advances in methodology, the disintegration test was found to be too insensitive, and dissolution test methods were introduced in the USP in 1968. Experts deliberated that Dissolution is principally useful as a Quality Control test and is poised to gain importance as a research and development (R&D)tool for Indian academic institutions and pharma industry. Organised under the guidance of founder president of SPDS, Vijay Kshirsagar chief executive officer, of Track Consultancy,  Dr Nandakumar Chodankar, chief executive officer, A Solution Pharmaceuticals and the organizing secretary, Dr L Ramaswamy, managing director of Sotax India, the scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD, Pharmaceutics, Bombay College of Pharmacy, Mumbai. Speakers deliberated on new technology, innovation and issues related to dissolution. Around 150 delegates from industry and academia attended the event.  Sotax India was the platinum partner of the event. "Traditionally developed for solid oral dosage forms, use of dissolution testing has been widened to a variety of dosage forms such as semi solid, liposomes, nano particles, parenteral preparations in the last few years," explained Dr Ramaswamy. The event comprised of plenary lecture, poster exhibits, panel discussion and exhibits. Speakers drew the conclusion that a lot of progress has been made during the last three decades from the aspect of standardisation and harmonisation of regulations. Vijay Kshirsagar, director, TRAC Consulting, Mumbai spoke on the Relevance of Current Batch Centric BE Studies, Dr Vinod Shah, Ex. US FDA, Pharmaceutical Consultant, USA spoke on FDA/USP Perspectives on Dissolution Testing from Regulatory Filing point of view. Prof. Dr Jean Michel Cardot, Professor, Department of Biopharmaceutics, and Pharmaceutical Technology, Auvergne University, France spoke on In-Vitro Dissolution as in Vivo Surrogate; Samir Haddouchi, Managing Director, SPS Pharma Services, Clermont Ferrand – France spoke on Challenges and Solutions to Dissolution Testing of Non-Oral Formulations; Dr. Umesh Banakar, Professor and President, Banakar Consultancy Services, USA spoke on Biosimilars - The Emerging Frontier for Generics: Role of Dissolution Testing; and Michel Magnier, Product Manager, SOTAX AG spoke on Automation for Dissolution Testing. Bryan Crist, Manager, Scientific Affairs, Agilent technologies, USA spoke on Validation of Components and data of Automated Dissolution Methods; Prof. Dr. Sompol Prakongpan, Professor of Pharmacy, Burapha University, Thailand spoke on Biowaiver of Biopharmaceutics Classification System Class III Drug Products; Dr. Sid Bhoopathy, Chief Operating Officer, Absorption Systems, USA spoke on Strategies for Establishing Equivalence of Complex Drug Products and Dr. Flavian Stefan Radulescu, University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania spoke on Correlation between rheology, in-vitro release and in- vivo performance of topical dosage forms. The International Symposium was inaugurated by Dr. GD Yadav, the Vice Chancellor of Institute of Chemical Technology (ICT), Mumbai. Dr.Vatlamudi Rao, who is the current President of IPA ( Indian Pharmaceutical Association) was the Guest of Honor. In his address he has expressed that IPA shall support SPDS and do collaborative programmes across the country. SPDS also launched a Desk Book of Pharmaceutical Dissolution Science on the occasion authored by more than 10 eminent authors and edited by Dr Sandeep Tiwari, Dr.Umesh Banakar and Dr.Vinod Shah. Dr. Vinod Shah and Dr. Umesh Banakar were awarded  with the SPDS excellence award for their immense contribution to the field of Dissolution Science by president Vinay Kshisagar and the Dr. Mangal Nagasenkar, Scientific Committee chairman and the organisers. There was also a Panel Discussion on “Handling dissolution Challenges” by eminent professionals from the Pharmaceutical Industry. Specifically designed for all the professionals from R&D, QA and QC as well as the Academia, SPDS is planning to organise DISSO America in USA next year.

FDA Nagpur takes action against retailers & wholesalers for non-compliance of norms

Shardul Nautiyal, Mumbai Saturday, May 10, 2014, 08:00 Hrs  [IST]

The Maharashtra Food and Drugs Administration (FDA)'s  Nagpur Division has cancelled 364 drug licenses of retailers and 12 drug licenses of wholesalers in the revenue year 2013-14.  The licenses have been cancelled for non -compliance to the Drugs and Cosmetics Act on the basis of inspections of 4,190 retailers and 1,265 wholesalers in Nagpur Division last year. According to official reports, FDA has gained an overall performance of 79.25 per cent in the previous year. There are 4,574 retail medical stores and 2,315 wholesale stores in Nagpur division.  Expressing satisfaction over the work of FDA Nagpur division, a state FDA official said that there has been a lot of awareness among common people and the department received about 3 to 4 complaints every day last year. Besides this, the division has 120 manufacturing units. FDA has completed inspections of all these units in the last one year. FDA has given show cause notices to 23 units and canceled licenses of five units, six licenses were suspended, warnings were issued to five units while eight cases are pending. Around 84 samples were declared sub standards on analysis by the government analysts out of the 521 samples of medicines collected by the FDA last year. Nine cases were filed on sub-standard medicines and eight cases were filed under other categories. The FDA has also taken action against two firms for violation of the provisions of Drugs Price Control Order (DPCO) and seized stock of medicines worth Rs. 1,48,675 and registered 10 FIRs under Drugs and Magic Remedies Act. Two firms were also fined Rs. 1,20,000 for selling sub standard medicines and ayurvedic medicines worth Rs. 50,000 were also seized.

Maha FDA cancels licenses of 5452 retailers, suspends 3178 for violation of D&C Act

Shardul Nautiyal, Mumbai Wednesday, May 14, 2014, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) has canceled licenses of 5452 retail pharmacies and suspended licenses of another 3178 retailers across the state in the year 2013-14 for violation of Drugs and Cosmetics Act like dispensing medicines without prescription and without proper bill. During the year, the FDA had conducted inspections on 48086 retail stores in the state. The FDA's crackdown is in line with the fact that there is irrational usage of around 65 per cent of antibiotics and cancellation of licenses is done based on the non-compliance like dispensing medicines without prescription and without bill. It has been reported that there is only five to six per cent billing on sales across Maharashtra. During the year, the FDA had inspected 5469 retail stores in Greater Mumbai, 7143 in Konkan, 11,801 in Pune, 6855 in Nashik, 4574 in Nagpur, 8097 in Aurangabad and 4147 in Amravati FDA divisions. Around 901 licenses were canceled and 693 suspended in Greater Mumbai alone. Maximum number of 1384 cancellations were done in the Konkan Division followed by Mumbai, Pune with 896 licenses, Aurangabad with 801, Nashik with 612, Amravati with 489 and Nagpur with 369. According to FDA officials, compliance to Schedule H1 is being pursued on a war footing by educating retailers.  Maharashtra FDA Commissioner Mahesh Zagade convened meetings in Nagpur, Nashik earlier and in Mumbai recently to sensitise retailers about the Schedule H1 compliance. The union health ministry had amended the D&C Rules to insert Schedule H1 to regulate the use of antibiotics in the country, and had placed 46 antibiotics under this category. Similar kind of actions have also been taken by FDA under the Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act). Against the backdrop of several instances of violations to DMR Act last year, FDA has recently filed First Information Report (FIR) against a Mumbai based weight loss firm this year. FDA had served 1434 notices and filed 58 FIRs last year. Prosecution is going on for four cases.