Maharashtra is the leader among states in India in many ways. It is way ahead of the other most-industrialised states in utilisation of both labour and capital according to the Annual Survey of Industries (ASI). At Rs 1.03 lakh, Maharashtra has the second highest per capita income as compared to other major states in the country, according to the state Economic Survey.
After a crippling drought that plagued large parts of Maharashtra last year, the state economy seems to be on the upturn. The Economic Survey of Maharashtra for 2013-14 has stated that as per the estimates the Gross State Domestic Product grew at a rate of 8.7 per cent in 2013-14. Last fiscal, the growth was 7.1 per cent.
And with the improving regulatory as well as IT governance scenario, matchless Maharashtra is all set to scale greater peaks in the pharmaceutical landscape also.
The pharmaceutical players in Maharashtra are moving ahead strongly with entry into new markets, launching new products, R&D investments, filing more numbers of ANDAs and DMFs in highly regulated market. Though the competition and quality problems are impacting the short -term working, the long- term outlook seems to be positive. Out of 100 listed Pharmabiz entities, the Maharashtra- based players are controlling a major portion of 41 per cent of aggregate net sales on account of higher international as well as domestic presence. For the first quarter ended June 2014, major companies like Lupin, Glenmark Pharmaceutical, Ipca Laboratories and Indoco Remedies registered strong growth in revenues and profits. However, Pfizer, Novartis and Unichem Laboratories failed to generate higher growth in the first quarter of 2014-15.
Maharashtra accounts for 17 per cent exports and 20 per cent of drugs manufactured from India. It therefore becomes evident that there is a need for monitoring at the local level to evaluate quality and quantity of drugs supplied to foreign countries. Maharashtra FDA has also initiated efforts to ensure that drugs are manufactured as per global GMP norms.
Aimed at further evolving the pharma manufacturing landscape, the Maharashtra FDA besides launching an online Extended Licensing Node (XLN) system for easy and timely access and approval of manufacturing licenses has a bouquet of other offerings too. Other unique offerings include WHO GMP certificates in 10 days coupled with regulatory initiatives by the state regulator like enforcement for compliance to Drugs and Cosmetics Act with reference to Schedule H1, compliance towards discouraging irrational usage and overpricing of drugs, action against illegal online pharmacy trade and recommending medical devices to be brought under Drug Price Control Order (DPCO) in the wider interest of the patients which have been lauded by the industry as indicators for growth.
As far as clearance of regulatory approvals are concerned, Konkan division of Maharashtra Food and Drug Administration alone has cleared 50 percent of the 800 applications for manufacturing licenses in the stipulated 48 hours time after the introduction of online Extended Licensing Node (XLN) system in May, 2014. The system was introduced in the division recently as a part of the state FDA's drive to speed up the issue of licences and certificates in the state online.
Says an official associated with the development, "The system has been able to simplify the process of granting certificates and licenses by virtue of the fact that procedures now happen in three stages as compared to the eight stages earlier which has considerably brought down the time taken due to bureaucratic hassles."
With system being currently implemented at Pune and Nashik, Maharashtra FDA is planning to introduce the online system across the state in order to accomplish timely disposal of renewal of licenses, testing licences, licences for additional products, performance certificate and free sale licences among others.
The XLN system, according to a senior FDA official would be a boon for over 1703 existing manufacturing units across the state as system will deliver online approvals for over 6 certificates required by pharma manufacturing units. The state FDA receives 8000 to 10,000 applications in a year for manufacturing licences.
Maharashtra FDA boasts of issuance of 86,000 new product licenses of which Konkan FDA division alone issued maximum number of 46,305 licenses followed by Nashik, Pune, Nagpur, Greater Mumbai, Aurangabad and Amravati during 2013-14.
Upgrading drug testing infrastructure
In order to make drug recall faster and more effective, the Maharashtra FDA is in the process of upgrading the drug testing infrastructure in the state. This would help in considerable reduction in downtime with samples being tested in a mere three days time as compared to three months earlier.
As a part of the upgradation process, land for the upcoming labs at Nashik and Pune have been finalised. A plot of two acres have been identified at Nashik for setting up a modern drug testing lab. Nagpur lab has been spruced up and plans to come up with a lab at Pune is also ready.
Says a senior FDA official, "Drawing drug samples, analysing them for safety and drug recall will get a boost with the upgradation of drug testing infrastructure. This will make the information on substandard and not-of- standard drugs reach the patients and chemists at the very moment it is analysed and tested. Drug recall is a very arduous task as it has been realised that not-of-standard drugs remain in the market for 62 days on an average before it is consumed by the patient. Timely analysis and effective drug recall is therefore the need of the hour."
FDA tested 6097 samples last year, found 466 not-of- standard drugs and filed 101 cases. According to official sources, the failure rate of not-of-standard drugs is 4.67 per cent in Maharashtra as compared to 8 per cent failure rate outside the state. Around 7538 samples were drawn in the year 2012 -13 of which 360 were found not-of-standard.
"Lab at Nagpur will be operational soon as there is some pending civil work required to be carried out and procurement of equipment is going on. We are also simultaneously working on other projects in consultation with engineers and architects," the official informed.
Currently FDA has only two drug testing laboratories one at Mumbai and another at Aurangabad. The drug testing laboratory located at Mumbai is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Regulating overpricing of drugs
The Maharashtra FDA has also asked the union health ministry to initiate immediate measures to make paracetamol syrup 125 mg available in the market across Maharashtra as the manufacturers have stopped manufacturing it as it has impacted their profitability due to it being regulated under the new DPCO 2013.
According to sources, the Maharashtra FDA has asked both the Drug Controller General of India (DCGI) and the national drug price controller National Pharmaceutical Pricing Authority (NPPA) to immediately intervene in the matter as the state is facing severe shortage of Paracetamol syrup 125 mg.
As per the Maharashtra FDA's findings, it has been given to understand that Paracetamol Oral Suspension 125 mg which falls under the non-controlled category in the current pricing regime is abundantly available in the market across the state. While, on the contrary, paracetamol syrup is not available as manufacturers have stopped manufacturing it as it has impacted their profitability due to it being regulated under the new pricing regime or DPCO.
Moreover, it has been found that manufacturers are selling paracetamol oral suspension 120 mg and paracetamol oral suspension 125 mg at different prices claiming that it does not fall under the new Drug Price Control Order (DPCO). Whereas paracetamol syrup 125 mg in 60 ml volume is sold at Rs.20.79 as per the DPCO, paracetamol oral suspension has been injudiciously priced between 127 per cent and 157.5 per cent more by some manufacturers. It is learnt that the manufacturers have tried to offset the losses due to sales on medicines in controlled category by raking in profits on the non-controlled category through overpricing.
The FDA has urged the NPPA to bring a uniform pricing policy so that essential medicines which fall under the National List of Essential Medicines (NLEM) could be brought under the controlled category for making it affordable and accessible.
WHO GMP certification
FDA 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).
Though there is a need for improvement in the quality standards with the latest setback in the form of Vietnamese authorities decision to impose a ban on imports from Indian companies due to poor safety standards, FDA's monitoring mechanism of drugs is bound to help in a big way.
There are around 883 allopathic manufacturing units in the state of which Konkan division has 419 units. Pune has 135 units, Greater Mumbai has 124 units, Aurangabad has 75 units, Nashik has 70 units, Nagpur has 40 units and Amravati has 20 units. Konkan has also taken a lead in the number of batches produced by manufacturing over 1lakh 82000 batches followed by Pune and Aurangabad.
As per official sources, drugs worth of Rs.35, 000 crore were purchased in the year 2013-14. Monitoring of sale of drugs exported and purchased locally by FDA has been done to maintain accountability in drug trade in the backdrop of global scrutiny in terms of GMP compliance.
FDA has found that out of the 3 lakh 5000 batches of drugs produced from the state, drugs worth Rs.19 lakh 892 were purchased domestically and exports accounted for Rs.15,500 crore.
Regulatory initiatives
Enforcement for compliance to D & C Act and DMR Act
The Maharashtra 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. FDA officials convened meetings in Nagpur, Nashik earlier and in Mumbai 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.
Compliance to discourage irrational usage of drugs
Taking into account the WHO's latest report on antimicrobial resistance, which reveals antibiotic resistance as a burgeoning problem in South East Asia, FDA has appealed to the chemists to comply with Schedule H1 on an urgent basis.
The FDA has made it clear to the chemists about compliance to Schedule H1 in the wake of the findings that there is irrational usage of around 65 per cent antibiotics. It has therefore been mandated that the prescription should compulsorily bear the doctor's name and correct dosage regimen in accordance with the law of the land.
Explains an FDA official, "Schedule H1 compliance is very much necessary as Maharashtra accounts for Rs. 1500 per capita consumption of drugs as compared to the national average of Rs. 694. While talking about the existing scenario, he pinpoints that the country is currently facing a scarcity regime as no new drug class has been launched since 1987 to tackle infections caused by multi-resistant bacteria."
Daptomycin was the last one launched in late 1980s. Daptomycin is a lipopeptide antibiotic used in the treatment of systemic and life threatening infections caused by Gram positive organisms. Citing the WHO report, which focuses on antibiotic resistance in seven different bacteria responsible for common and serious diseases such as bloodstream infections (sepsis), pneumonia, urinary tract infections and gonorrhoea, an FDA official informs that it also includes diarrhoea. That is why, it becomes imperative that right kind of dosage regimen needs to be adhered to. Echoing similar views, pharmacology expert Dr R P Agarwal has also recommended strict and exact adherence to dosage regimen of prescription medicines to tackle antibiotic resistance.
Argues Ashok Khandelwal from Healthcare Advocacy group Chikitsasansar, "Today non-compliance to Schedule H1 compliance will have serious implications as drug wholesalers are promoting irrational usage of drugs in the name of new antibiotics by illegally selling it to quacks. Drug Controller General of India (DCGI) needs to take appropriate action as it has been found that medical representatives appointed by drug companies in order to meet their targets promote antibiotics to unqualified allopaths and these in turn prescribe medicines to patients irrationally with the motive of getting hefty commissions. This has led to rampant quackery on one hand and disillusioned healthcare practitioners and patients on the other hand as drug usage most of the times is not backed by valid information on pharmacology."
WHO’s report results show high levels of E. coli resistance to third generation cephalosporins and fluoroquinolones—two important and commonly used types of antibacterial medicine– in the South East Asian region. Resistance to third generation cephalosporins in K. pneumoniae is also high and widespread. In some parts of the region, more than one quarter of Staphylococcus aureus infections are reported to be methicillin-resistant (MRSA), meaning that treatment with standard antibiotics does not work.
Most of the chemists across Maharashtra have yet to follow the newly amended Schedule H1 effective from March 1, 2014 due to lack of awareness and cumbersome record keeping. Non-compliance of Schedule H1, a senior FDA official says, will attract penalty ranging from lodging FIRs and cancellation of licenses based on the merit of the case.
The Central government in September 2013 had amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this category.
Online pharmacy racket
Concerned over the increasing incidents of illegal sale of prescription drugs through websites, the Maharashtra FDA has written to the Drugs Controller General of India (DCGI), Director General of Foreign Trade (DGFT) and the union commerce ministry to prepare an action plan to put an end to this clandestine activity. Stating it as a nationwide phenomenon, an FDA official informed that the state regulatory body is in constant touch with DCGI to plug the loophole in the regulatory system and take appropriate action under the D&C Act before it culminates into an alarming situation.
It has been given to understand that selling of prescription drugs through online is a huge racket as foreign buyers can obtain prescription drugs including addictive anti-depressants, anti-hypertensives and those containing sildenafil citrate (a key component in drugs for erectile dysfunction also used to treat pulmonary arterial hypertension) easily and beat stringent rules in their local markets.
According to a senior FDA official, it is a very difficult operation as underworld is involved in it and has been a subject of interpol operations for the past several years. Operations in around 100 countries globally are going on to tackle this menace as it is ant-social and detrimental for future generations. Transactions are made online through thousands of websites to evade local rules.
FDA has till date seized drugs worth over Rs. 2 crore from various parts of the city over the last one month and canceled 12 licenses.We are still investigating the matter and more such companies might face action for illegal sale of drugs without a license and prescription in contravention to Section 18 C and 18 (a) (6) of D&C Act and may attract penalties under Section 27 (b) and (d) of D&C Act ranging from 3 years imprisonment or fine upto Rs. 10,000 or 5 years imprisonment or fine above Rs. one lakh. According to sources, more than 20 Indian companies are involved in the racket.
But FDA officials beg to differ and say, "We are yet to ascertain the magnitude and quantum of the racket as distributors in India tie up with agents abroad after which the drugs are dispatched as per the order. Most of the drugs seized till date had invalid prescriptions. Our dialogue with DCGI, DGFT and Commerce Ministry is aimed at addressing this problem in totality on an urgent basis."
Medical devices
Maharashtra FDA has recommended to the Drug Controller General of India (DCGI) and National Pharmaceutical Pricing Authority (NPPA) to bring medical devices including drug eluting stents (DES) under the Drug Price Control Order (DPCO) 2013 to make it affordable to the patients.
Medical devices including drug eluting stents (DES) are notified as drugs under the Drugs and Cosmetics Act, 1940 but is not included under the DPCO. Therefore, the prices of medical devices cannot be monitored and controlled as of today.
The recommendation comes in the wake of studies conducted by the FDA which has revealed that manufacturers in connivance with importers, distributors and hospitals are fixing the MRP of medical devices arbitrarily which is then passed on to the gullible patients. It was observed from the studies that the Maximum Retail Price (MRP) of the imported drug eluting stents is exhorbitantly high and patients have no option to bargain.
FDA, therefore has recommended that in order to monitor and control the prices of medical device including DES, the term medical device including DES should be included under the new DPCO regime.
The MRP of DES is fixed by the importing company. As the manufacturers of these devices are located overseas, it is difficult to study the manufacturing cost and export prices of these devices. Besides this, the startling fact is that the cost of DES is immediately recovered from the patients but payments to the distributors are made after a period of 60 to 120 days. The payments of applicable taxes of the concerned sale transactions, to the state government are made only within 51 days by the distributors.
Patients were being forced to pay double or even triple the price for medical devices at hospitals. As most of these are not available in the open market, patients can't check prices and are held hostage by the hospitals, which force them to buy at the price they quote.
However, experts also opine that having an MRP has not prevented profiteering in medicines, with the MRP being fixed high enough to accommodate commissions since there is no limit on what the MRP can be. Moreover, while MRP is mandatory on everything manufactured in India, many devices are imported and escape this stipulation. In most hospitals, if two devices are more or less equal, the choice of which one is used depends on which fetches the hospital a bigger cut.
Ayurvedic clusters
To bring in standardization for small ayurvedic manufacturers and to help them grow their manufacturing businesses, the Ayush department has set up two clusters in Maharashtra namely 'Konkan Cluster' and MAC- Pune Cluster to facilitate the licensed manufacturers get more common facilities through the cluster approach. The Konkan Cluster has been set up under the company - Konkan Ayur Pharma Pvt Ltd.
The second ayurveda industry cluster Maharashtra Ayurved Centre Pvt Ltd. (MAC) under the Centre's Ayush scheme has been developed at Kolewadi of Pune district.
The approach of the cluster to involve 35 to 40 manufacturers ensures a common facility for around 15 different sections like tablets, capsules, powder, syrup etc but would also offer advanced lab testing facilities under one roof thereby enhancing efficiency, authenticity and efficacy of the product.
Speaking about the success of MAC - Pune cluster, Dr Sunita Belgamwar, chairperson of MAC explains, "The cluster has given us an opportunity to develop a 360 degree horizontal model to propagate concepts and principles of Ayurveda to the farmers, traders, doctors, researchers, pharmacists and other stakeholders through interventions like exhibition, new drug and process design for mass production, contract manufacturing, raw material processing and sale, quality control lab and entrepreneurship development centre."
These cluster projects would bring about quality improvement of raw material and finished goods, reduction in the individual capital investment through contract manufacturing, reduction in the pre manufacturing time (40 per cent time saving) by virtue of bulk raw material supply, reduction in the packaging and labeling costs through a common facility centre, reduction in marketing costs by common marketing and branding (40 per cent cost saving), development of new drugs, process design and validation to compete globally, IPR protection and assistance in R&D and global exposure through common exhibitions.