CPhI innovation awards open for entries

Leading events organiser UBM Live has announced details of the eighth edition of the CPhI Innovation Awards and issued a call for entries. Winners of the annual awards, which recognise, celebrate and honour companies that are innovating and breaking new ground in the pharmaceutical industry, will be announced at UBM’s flagship pharma ingredients event, CPhI Worldwide, which is being held this year at Messe Frankfurt, Frankfurt, Germany from October 25-27, along with co-located events ICSE for contract services, clinical trials and packaging; InnoPack for pharmaceutical packaging solutions; BioPh for the biopharma sector and P-MEC Europe for equipment, machinery and technology.

Entries are being invited from exhibitors across all the events in Frankfurt and entry categories for the 2011 Awards have been expanded, reflecting the new zoned layout of the events. This year, submissions will be accepted from the following areas: APIs, Custom Manufacturing, Intermediates, Excipients/Formulation, Fine Chemicals, Finished Dosage, Contract Services, Drug Delivery Systems and Biopharmaceuticals. The deadline for submissions July 29, 2011. Details on how to enter can be found at: www.cphi.com/innovation-awards.

“The CPhI Innovation Awards are an extension of our pharma event brands, effectively the industry’s leading events recognising the industry’s leading innovators. The profile of the awards has grown significantly since their inception in 2004 and they now provide our exhibitors with a high profile, global platform with which to showcase their cutting edge developments,” commented Annemieke Timmers, brand director CPhI. “Last year, the Awards attracted a record thirty entries and we hope to build on this further in 2011. The awards will again be judged by our expert panel who will be looking to highlight achievements, ideas, technologies and products of organisations that truly embrace innovative technology and demonstrate tangible long-term benefits to the pharma industry.”

Comprised of senior personnel from some of the industry’s leading pharma organisations, the judging panel for the Innovation Awards has remained consistent since 2007 and includes Dr Hendrik Baumann - CU Chemie Uetikon, Zoran Buncic – Pliva, Dr Didier Bensoussan - Dr Reddy’s Laboratories (UK) Ltd., Dr Hans-Leonhard Ohrem - Merck KGaA and Dr Andreas Stolle - Saltigo GmbH. Having reviewed the entries, the panel will announce a shortlist of six entries on September 12 , 2011 and these companies will present to the panel in Frankfurt on October 25, with the Gold, Silver and Bronze Award winners being announced at a ceremony that evening. The three runners-up will be recognised with a nominee certificate.

“The Innovation Awards traditionally attract entries from all spheres of the global pharmaceutical industry, from small biotech companies to the pharma majors, and previous winning entries have ranged from ligand production techniques to reactor efficiency enhancements, to the delivery of probiotics to infants through breast milk,” commented Haf Cennydd, brand director ICSE, P-MEC, InnoPack and BioPh. She added, “By introducing an expanded range of submission categories, we expect to see an even greater diversity of entries than in previous years.”

For further information on the 2011 Awards and to submit an entry, visit: www.cphi.com/innovation-awards.

GVK Biosciences extends license of their biomarker database (GOBIOM) to US FDA

GVK Bio have extended their biomarker database (GOBIOM) license to the biomarker qualification group of the US Food and Drug Administration (US FDA).

The GOBIOM database is a comprehensive collection of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. It contains information on 12,000 biomarkers comprising of biochemical, genomic, imaging, metabolite, cellular and physiological markers with multiple data points covering experimental, analytical, clinical and statistical data with their qualifications under different medical interventions. According to GVK Bio, the GOBIOM database, which has the latest and updated information on all the biomarkers reported in various clinical and preclinical studies, will be of enormous use to US FDA in their qualification process.

The license has been extended for a period of one year and the license is perpetual in nature. Financial terms of the same has not been disclosed.

Madras HC postpones hearing on banned drugs case to April 26

The Madras High Court has once again postponed the hearing on the interim stay allowed by the court on banned drugs case on March 15. The next hearing on the issue will be held on April 26.

In the stay order dated March 15, the Madras High Court had allowed 15 days time to the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA), which were banned in the country on February 10 this year by the union health ministry along with some other drugs that were found to make adverse effects on human health.

This is the second time the court has postponed the hearing in the case. Earlier, on March 31 the court had postponed the hearing to April 18 as the respondents, the health ministry and the DCGI, did not appear in the court on March 31.

Meanwhile, the postponement of further hearing on the case will give more time to the drug companies to liquidate their stocks of these banned drugs. A petition on this issue was filed by Confederation of Indian Pharmaceutical Industries (CIPI), an association of thousands of small pharma companies in the country.

Earlier on March 23, the court had merged this CIPI case with another similar case filed by pharma major Cipla Ltd.

Hearing the petition filed by Cipla on March 23, the Madras High court had stayed the entire notification of the ministry (GSR 82 E) dated February 10, 2011 in which it had banned six of the most controversial drugs in the country with immediate effect. These drugs included the non-steroid anti-inflammatory drug nimesulide (below 12 years age), gastroprokinetic agent Cisapride, decongestant drug Phenylpropanolamine (PPA), human placenta extracts, Sibutramine & its formulations and R-Sibutramine & its formulations.

In a gazette notification dated February 10, the ministry had banned these controversial drugs due to its adverse effects on human health.The ministry's decision in this regard was based on the recommendations of the Drugs Technical Advisory Board (DTAB), which is the highest decision-making body under the union health ministry on technical matters and its recommendations are normally followed by the ministry. Earlier, the DCGI had brought these controversial drugs under the radar of the DTAB in the wake of serious concern raised by the medical experts in the country over the side-effects of these drugs.

Trial, and many errors

About 14,000 girls, aged between 10 and 14 years in the Khammam district of Andhra Pradesh were vaccinated with the human papilloma virus (HPV) vaccine as part of a study on the efficacy of the vaccine against cervical cancer last year. These girls were mostly tribal children whose parents were agricultural labourers. The public outcry following the death of six of the girls led to the government suspending the study. It was later found that there were several violations of existing protocols. The parents of the girls, who were staying in hostels, were never informed. Instead, consent was taken from the wardens.

The government denies that the HPV vaccination was a clinical trial. Whether it was a trial or a study, there is no denying that the dramatic explosion in the number of clinical trials being conducted in India - from just about 100 in 2005 to over 1, 000 in 2010 - is leading to concerns about the safety of those recruited for the various trials.

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IMS Health India launches total sales audit

IMS Health India recently launched a new sales audit–TSA (Total Sales Audit), which provides a 'complete and comprehensive' picture of the pharmaceutical industry. Upto now, IMS Health Information and Consulting Services India IMS Health India, which is a 100 per cent subsidiary of IMS Health, used to capture retail and hospital sales through the Stockist Secondary Audit (SSA) and Hospital Secondary Audit (HSA) respectively. But these two audits capture only around 85 per cent of the Indian pharma sales market.

The remaining slice of the pie is now available as a Doctor Sales Audit (DSA). A miniscule sales channel, that of speciality products like certain medications in nephrology and oncology, that are purchased by patients directly from stockists, as they are too expensive and require special storage conditions, to be stocked at sub-stockists, is still not captured.

All the data will be integrated into one single product and offered on one platform, with updates available on a monthly basis for all business segments. The TSA computed on MAT December 2010 data has some surprises for the industry, in terms of rankings (of companies and brands) and growth rates in different therapy areas. For the first time, industry analysts can compare growth rates of therapy areas across the three main pharma sales channels in India: retail, hospitals and doctors.

Giving more details, Sameer Savkur, managing director, IMS Health India, says, “This raises the worth of the total audited pharma market from Rs 46787 crore to Rs 54849 crore. While SSA contributes 85 per cent, HSA accounts for nine per cent and DSA for six per cent of the pie.” Comparing the SSA with the TSA, the latter has improved capture of certain therapies. For isntance the vaccines market capture improves by as much as 60 per cent, by Rs 490 crore.

New rankings

While the TSA and HSA rankings for the top seven companies show no changes, it’s interesting to note that GSK, at third position, is closing the gap between Ranbaxy at the second place, thanks to its hospital sales. In fact, GSK is number one in the HSA with Sun Pharma and Cipla coming second and third. GSK also tops the DSA, with Piramal Healthcare and Cipla at second and third positions respectively.

Among the top-20 companies the following improve their ranking as compared to SSA: sanofi aventis (+3), Pfizer (+1), and Micro Labs (+1). While Pfizer and sanofi aventis benefit on account of their strong hospital portfolio as well as vaccines business which provides them with a sizable franchise among doctors, Micro Labs moves up on account of its relatively stronger combined hospital and doctor sales (relative to others companies close to its ranking).

Companies who drop in rankings (in TSA as compared to SSA alone) as a result of the above changes are Mankind (-1), Aristo Pharma (-1), Intas Pharma (-1) and Dr Reddy’s Labs (-1).

FDA approves Rituxan to treat two rare disorders

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells.

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclosphosphamide.

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

Health ministry finalises 9-member panel to study efficacy, safety of human placental extract

The union health ministry has finalised the 9-member expert committee to go into the issue of efficacy and safety data of human placental extract which has been banned by the government along with some other controversial drugs including the non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent cisapride and decongestant drug Phenylpropanolamine (PPA) on February 10 this year.

Renowned pharmacologist Dr YK Gupta of AIIMS will head the panel. Other members of the committee include Dr Ajay Kumar of IMA, Dr Vijay Kumar of IDRI, Dr Sharma of ICMR, Dr Kotwal of AIIMS, Dr VK Tiwari, Dr VK Chakravorthy, Dr CM Sharma and Dr Lakhbir Dhaliwal of PGI, Chandigarh.

The expert panel has been constituted by the ministry on the directive of the Delhi High Court which heard a petition on April 6 by the Kolkatta-based pharma company Albert David Ltd, which was a pioneer in human placental extract therapy, for staying the government notification in which the controversial drugs were banned in the country.

Refusing to grant stay on the ministry's notification banning the controversial drug human placental extract, the court asked the government to constitute a 9-member expert committee to go into the issue of efficacy and safety data of human placental extract. The expert committee has been asked to submit a report on the matter by May 15 this year.

The union health ministry had banned several controversial drugs including human placental extract following the Drugs Technical Advisory Board (DTAB)'s recommendation to the ministry to ban these drugs after it was found by the Board that these drugs will have adverse effects on human health. The DTAB is the highest decision-making body under the Union health ministry on technical matters.

Human placental extract was one of the controversial drugs which was under the radar of the health ministry for some time. In India, human placenta extract sold as Placentrex lotion, gel and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.

But, that is not the case in the international market, especially in the developed countries. According to reports, all products containing extract of human placenta have been banned by the US FDA since they can transit diseases and pose serious health hazards to consumers. Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.

DTAB recommendations to re-examine many FDCs likely to prolong issue further

Even as the sub-committee of the Drug Technical Advisory Board (DTAB) is meeting for two days from today, the vexed issue over Fixed Dose Combinations (FDC) is unlikely to be settled early, as being reiterated by the authorities.

The process of clearing the FDCs is going to be long-time affair as the sub-committee is scheduled to re-examine a number of FDCs already cleared by them earlier. Apart from this, the panel will also assess 64 FDCs, out of the remaining 80 FDCs to be covered, according to the agenda fixed for sessions spread on April 19 and 20.

The sub-committee will also examine six FDCs approved before 1988, as per the decision taken by it in the meeting held on October 1, 2008. They include dicyclomine+mefenamic acid+ paracetamol, dicyclomine + paracetamol + clinidium bromide, dicyclomine + paracetamol + clinidium bromide + chlordiazepoxide, mefenamic acid + dicyclomine, paracetamol + dicycloverine + mefenamic, and propranolol + Diazepam.

The meeting will re-examine a set of 22 FDCs for rationality, as per the recommendation of the meeting of DTAB. They fall in the categories of nutritionals, orthopaedics, and antihistamines. They have been already cleared by the expert panel, but the 57th meeting of the DTAB has directed re-examination of the same.

Likewise, another set of 16 FDCs will also be re-examined by the panel for rationality, as per the direction of the last DTAB meeting. These combinations are of antimicrobial with lactic acid bacillus and had been discussed by the sub-committee at its meeting on January 23 and 24.

Thus in total, the two-day meeting of the sub-committee has to clear 107 FDCs after examining the rationality. The recommendation by the DTAB for re-examination would further prolong the process of putting a final solution to the vexed issue of FDCs, though DCGI had recently claimed that the matter would be solved within one month.

CPCSEA directs institutions, pharmacy colleges to minimise use of animals in research

The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) has issued a directive asking all the institutions and colleges, approved by Pharmacy Council of India (PCI), to strictly follow the specific guidelines of Medical Council of India for the use of animals for carrying out experiments. In pharmacy colleges, a large number of animals are used by students for research and studies.

CPCSEA was constituted under section 15 of the Prevention of the Cruelty to the Animals (PCA) Act, 1960 which aims to ensure the humane and ethical use of animals, while facilitating research and experiments on animals.

The Act states that if the institution or establishment is not registered with CPCSEA then they will not be allowed to perform any experiment on the animals. PCI is insisting that all the institutions to minimise the use of animals for the experiments and if they have to perform any experiment or research they have to take the permission of CPCSEA then only they can do it.

Dipankar Chakraborthy, vice president, PCI informed that not only in the pharmacy institutions this act is enforced but also in the colleges where the dissection of animals is carried out. Some institutions where experimentation is carried on animals like for pharmcology work where some tissues of animals like frog or cockroach are taken out and then allowing the animals to die. According to the PCA act this can be reduced. PCI is advocating to use softwares for demonstrating the action of Drugs on animal without using the Animal whereever possible one such software was developed (Indian Journal of Pharmacology, Issue 6, Vol 35,2003).

The decision of the committee is to ensure that while conducting various types of experiments, in connection with medical research or education, animals are not subjected to avoidable pain or suffering. The main function of this committee is to register institutions carrying out animal experimentation and/or breeding; to consider approval of animal house facilities and to regulate use of animals in experimentation.

As per section 19 of Prevention of Cruelty to the Animals Act, CPCSEA can prohibit any institution for carrying out the experiments or the ongoing research on animals if it is not registered. Also the committee has the power to close the animal house facility if any institution or establishment is not registered within 60 days from the date of commencement.

DTAB sub-committee on FDC to meet on April 19, 20 after long gap

After a long gap of more than one year, the sub-committee of the Drug Technical Advisory Board (DTAB) on the issue of long pending Fixed Dose Combination (FDC) issue will hold a two-day meeting on April 19 and 20 and take a call on most of the remaining FDC drugs.

The much-awaited meeting of the panel, headed by the Drug Controller General of India (DCGI) and having representatives of major pharma associations along with the experts in the field, will examine as many as 64 FDCs during the sessions spread across two days, though as many as 80 odd FDCs, out of the controversial 294 FDCs, were still remaining to be assessed.

The panel will examine the feasibility and decide on the fate of FDCs belonging to dermatological, nutritionals, CNS, anti-microbial, anti-diabetic, orthopaedics, cough and cold categories, according to the list of FDCs shortlisted for deliberations at the meeting, sources said.

“The next meeting of sub-committee is scheduled to be held on April 19, from 11 am to 5.30 pm and on April 20, from 2 pm to 5.30 pm for examining the issues relating to the list of 294 FDCs,” said the letter from DCGI.

The expert panel on the FDC held its last meeting on February 24, 2010 and analysed 18 FDC products falling under the category of cardiovascular and diabetes therapeutic areas. The industry associations have been pressing for the next meeting for long now, with the hope that the FDC issue could finally be solved. The DCGI himself had announced in January that the issue would be cleared shortly.

The FDC issue became controversial when the then DCGI Dr M Venkateswarlu in June 2007 asked the state drug licensing authorities to withdraw licenses of the 294 FDC drugs for irrational combinations and the issue became a bone of contention between the industry and the DCGI. The industry then moved court and got stay order against the DCGI order from Madras High Court, which is yet to be vacated.

Hikma Pharma to acquire Indian-based Unimark Remedies for $33.3 million

Unimark Remedies Ltd (Unimark), India’s leading manufacturers of active pharmaceutical ingredients (API) and API intermediates recently informed that Hikma Pharmaceuticals PLC (Hikma) has agreed to acquire a minority interest in Unimark through the subscription of new equity for a cash consideration of $33.3 million.

The transaction is subject to certain conditions precedent and is expected to close in mid-May. It will be funded by a combination of cash and existing debt financing. KPMG India acted as Unimark’s sole financial adviser on the transaction and Yes Bank acted as Hikma's sole financial adviser on the transaction.

Commenting on the transaction, Mehul Parekh, managing director, Unimark said, “This partnership reaffirms Unimark’s strong capabilities in both the development and manufacturing of APIs and its growing presence in formulations for both emerging and developed markets. Hikma is amongst the world’s leading generic companies with a strong presence in the MENA, US and European markets. We look forward to working with Hikma to nurture a mutually beneficial and long term partnership."

Unimark’s broad product range includes betalactams, cephalosporins, carbapenems and covers a number of therapeutic segments including cardiovascular, anti-asthma and anti-infectives. Unimark operates three API facilities, two of which are US FDA approved, and two R&D centres, all of which are in India.

Commenting on the transaction, Darwazah, CEO, Hikma said, “Through this strategic partnership, Hikma and Unimark will collaborate on the development of strategic APIs and ANDAs. Unimark’s strong technical and R&D capabilities will complement Hikma’s in-house R&D efforts and are expected to enable Hikma to bring more products in more therapeutic categories to market globally. Unimark has an excellent reputation for quality and we look forward to working with their experienced management and operational teams.”

Health Min denies reports of proposal to make registration of brands mandatory

The Health Ministry has categorically made it clear that there is no proposal under consideration of the Government to bring in amendment to the Drugs and Cosmetic Rules to make mandatory the registration of all brands of medicines by the manufacturers.

The clarification comes in the wake of reports that the Government was considering a proposal to make it mandatory for the drug manufacturers to register all their brands, with a view to avoid duplication of brands in the market.

“The Health Ministry has not considered any such proposal now to change the rules of the Drugs & Cosmetics Act in this regard,” a senior official of the ministry said.

Earlier reports, quoting Union Minister of State for Chemicals and Fertilizers Srikant Jena, had said the government was having such a proposal under consideration and there was need to regulate the duplication of brands to avoid confusion.

The Pharma Department is learnt to have also held discussions with some industry associations on suggesting ways to regulate brands and one of the ideas emerged was the mandatory registration. However, the administrative ministry of the D&C Act is Health and it has now ruled out such a move.

The idea of mandatory registration of brands has been under discussion for some time now, as the regulatory officials wanted to have a centralised database to streamline the process of issuing brand names. Sources said, even a direction in this regard had come from the Supreme Court a decade ago asking the regulatory authority to co-ordinate with the trade mark office, but no action could be initiated so far.

Officials held that there were many common brand names by different companies in the pharmaceutical market and consumers were getting confused. Besides, companies also have variants of existing brand that are strikingly similar to a different product with a view to cash on the popularity of the successful brand names

APDCA begins recalling of gatifloxacin, tegaserod formulations

The Andhra Pradesh Drugs Control Administration (APDCA) has initiated the process of recalling drugs that involve gatifloxacin and tegaserod formulations, following a gazette notification issued by the Ministry of Health and Family Welfare, dated March 16, 20011, banning these two drugs due to certain health risks.

The notification prohibited manufacturing, sale and distribution of these two drugs with immediate effect. The Drugs Controller General of India (DCGI) sent letters to all the state drugs controllers on March 28, 2011, asking them to ensure that the manufacturing licenses granted in the respective states for the manufacture of these drugs formulations are cancelled with immediate effect and the formulations recalled from the market on top priority. It has asked the state drugs controllers to direct the chemists and druggists in the respective states to stop the sale of these formulations with immediate effect and to return the unsold stocks to the manufacturers. The DCGI letter also states that safer alternatives of these formulations are available in the market.

It is learnt that state drugs control administration has directed all the drugs inspectors to start recalling these drugs from the market. It has also asked all the manufacturers and distributors to stop manufacturing and distribution of these drugs.

According to an APDCA official, gatifloxacin, an antibiotic, is marketed under various brand names such as Gatiflo, Gatri, Gatispan, Gatiquin, Gatigo, Biogat, Q-gat and Gatri-OZ by different companies. Gatifloxacin is also used in several eye drops available in the market. Gatifloxacin is also available as tablets and in various aqueous solutions for intravenous therapy. It is understood that the decision to ban gatifloxacin was because it posed higher health risks.

Tegaserod formulations are used for the management of irritable bowel syndrome and constipation and marketed under the brand name of Tegibs.

Pondicherry gets independent Drug Control Dept from April 1, P Rajkumar appointed DC

The first Drugs Control Department of Pondicherry came into existence on April 1 with P Rajkumar as the Drugs Controller (HoD). An official Gazette notification in this regard was made a few days ago.

The cabinet decision in respect of the formation of a separate drugs control department was taken in the cabinet meeting held on December 29, 2010, and subsequently it was approved by the governor in the first week of January this year.

It was in April last year that the health ministry of the Pondicherry government took the decision to form a separate department for drugs regulation after bifurcating the Food & Drugs Control Administration. Following it, the health minister of the state, E Valsaraj made a statement in the assembly that an independent department could help revamp and streamline the functions of the drug control administration effectively. Soon steps for the establishment of a new administration were taken and an official from pharmacy section of the FDA was appointed as the controlling authority.

The drugs controller said since his office has now got independent charge, from now on he will report directly to the health secretary. So far the department was under the control of the Director of Health Services.

Till 1989, doctors from medical services were handling the drugs control administration. After the amendment of Drugs & Cosmetics Act in 1989, the post of a controlling authority was not notified in the union territory and the charge was being handled either by the commissioner or by the additional commissioners. To fill this vacuum, in July 2010, the government made the present drugs controller as the controlling authority without mentioning the term ‘drugs controller’, but provided the statutory powers for controlling the entire department. Prior to this appointment, Rajkumar was acting as the state licensing authority.

According to him, the government has sanctioned four more posts of drug inspectors and one post of assistant drug controller. All these appointments will be made soon after the election. Currently the posts of drug inspectors are four, out of which one post in the head office is lying vacant. Two ADC offices will be functioning in Pondicherry from June and one each from Karakkal and Mahe. Proposal for an independent analytical laboratory is also under the consideration of the government.

From 1964, the food and drug control administration was functioning under one Director with separate staff and facilities using same offices in the four regions of the union territory. Even though the bifurcation has been effected already, the office of the drug control department will be functioning in the same premises of the directorate of health services, Rajkumar told Pharmabiz.