Mayaderm Case Study

 Mayaderm

This is a product with proven therapeutic success and research backing. It can heal a range of cuts, burns and wounds that many ointments and creams fail to heal.  It has even helped patients avoid painful surgeries. I have received a patent on this formulation and praise from national and international quarters. My doctor colleagues from various health care specialties approve of the healing properties of the cream. I can confidently say that this is a unique product and one of its kind in the world. I have invested time and money into this venture, but have not been able to realize as much commercial success as the product deserves.  Its sales are not picking up. Recently, a third-party marketing agency that was appointed to sell the product through its newly-established dermatology department decided to close it. Maybe it is destiny. Maybe my understanding of how business works is not appropriate. However, being an optimist, I am looking for a breakthrough for Mayaderm. 

Dr. Chandubhai Fulchand Shah remarked as above as he reviewed the history and performance of his innovation on July 8, 2014.  Mayaderm was the outcome of consistent efforts by Dr. Shah to harness the medicinal properties of the leaves of Argyreia speciosa, a plant known in India as Samudra Shosh  (see Exhibit 1 for a description of the product and its healing properties). He shared his experiences at a seminar on traditional medicines organized by the Government of Gujarat at Saputara, in the western Indian state of Gujarat. The audience comprised of tribals (bhagats) with first-hand knowledge of local medicinal herbs, government officials, corporate executives and scientists. Dr. Shah recalled that his presentation was received very favourably with repeated applause. He had also received recognitions and awards from organizations in India and abroad for this innovation. In the last six years, between April 2008 and March 2014, he sold 101,830 tubes of Mayaderm; 70,830 of these were sold between April 2010 and March 2014. Over the years, expenditure on Mayaderm, especially the costs of promotion, distribution and production, had increased and the net margin had declined. Dr. Shah felt that the product was not selling as he had expected.

Dr. Shah

Dr. Shah, born in 1924, graduated in medicine and surgery from Seth G. S. Medical College and King Edward Memorial Hospital (K. E. M. Hospital) in Mumbai. As a medical student, he won a gold medal in clinical surgery in a competitive examination for juniors. He joined a Master’s programme in medicine but left shortly before completing it to pursue a Diploma in Venereology and Dermatology at the insistence of his professor in the Dermatology Department.  On completing the course in 1951, he joined Civil Hospital and its associated B. J. Medical College in Ahmedabad, Gujarat, as an Honorary Professor of Dermatology.  This position permitted him to pursue his private practice. In 1951, he set up a private clinic for treating skin diseases in a small space on Gandhi Road, a congested area of Ahmedabad. In 1953, he shifted his clinic to Oriental Building on Relief Road, a busy road that housed the offices of the Oriental Insurance Company. Some years later, in 1958, when insurance companies were nationalised and the building was taken over by the Life Insurance Corporation of India, he moved his clinic to Bombay Mutual Building, which was on the same road. 

After 15 years of teaching and consulting at Civil Hospital, he joined V. S. Hospital and its affiliated teaching institution, N. H. L. Medical College and Seth K. M. School of Postgraduate Medicine and Research, also a part of N. H. L. Medical College as a faculty member. He started a postgraduate course in Dermatology at Gujarat University. Dr. Shah recollected that in the early days of the programme, Dermatology was not a sought after specialization. Demand for this specialization increased when cosmetic applications for hair care and skin care were developed. He identified his distinctive competencies as clinical diagnosis and therapy. According to him, his inspiration for innovation came from his role as a therapist and practising clinician as he was open to alternative systems of medicine and traditional ways of healing. He got his ideas from Ayurvedic practitioners, casual contacts, books and magazines on medical practice, and even patients. As a member of the Association of Ayurveda Development and Research (AADAR), he had close contacts with Vaids (Ayurveda physicians), botanists and professors at Ayurveda colleges (See Exhibit 2 for a detailed profile of Dr. Shah). He continued his private practice after his retirement from V. S. Hospital in 1983. In 1990, he shifted his clinic to the first floor of Doctor House, a building that housed various specialists, including a diabetologist, cardiologist, pediatrician, dental surgeon, gynecologist and an ENT surgeon, and even had a nursing home.

Development of Mayaderm

The Trigger

As a medical student in 1945, Dr. Shah had observed that effects of Samudra Shosh in a case involving his niece who had a swelling on her scalp.  His teacher, the surgeon Dr. R. N. Cooper, asked him to wait till the boil matured before making the incision and draining it.  At that time, surgery was the only option, as antibiotics were not yet available in India. However, Dr. Shah found that the application of Samudra Shosh during the waiting period, by his gardner,  eliminated the need to operate on her scalp at all.   

The incident made a profound impression on him, and after joining B. J. Medical College,  he decided to learn more about the medicinal properties of the leaf. His chief guides were two books, both written in the Gujarati language: Kutchni Vanaspatio (Medicinal Plants of Kutch), and Vanaspati Shastra, written in the 19th century by a botanist named Jaikrishna Indrajit Thakor, who found that tribals and villagers used the leaf to treat ulcers and wounds. Dr. Shah later learned that Ayurvedic texts also mentioned Samudra Shosh, which was called ‘vraddhadaruka’ in Sanskrit, the language of ancient India.  Its roots and seeds also had medicinal properties. 

An Opportunity to Experiment

Dr. Shah very much wanted to perform clinical trials using the leaf to treat non-healing ulcers at Civil Hospital, but he was denied permission.  Herbal medicine was considered quackery at that time.  However, he got an opportunity to use the leaf in his private practice when he treated Dr. Somnath Shukla, a practising physician, for a deep, foul-smelling ulcer caused by the incision of an injection abscess in the gluteal region.  According to Dr. Shah, the ulcer was very difficult to treat because it was so large that one could almost put one's whole hand into the cavity.  The recommended treatment was to dress the wound with antibiotic ointment frequently as the ulcer would take a long time to heal. The alternative was to try to treat it with the leaf. Dr. Shah applied the leaf over the wound and observed that the ulcer healed completely in three weeks. His success in treating his colleague's ulcer convinced him that the leaf treatment was a superior alternative to the existing treatments.                                    

More Experiments

Dr. Shah wanted to develop an ointment harnessing the medicinal properties of the herb to make its benefits available to everyone everywhere. He was able to pursue this idea after he left Civil Hospital and joined V. S. Hospital as Head of the Dermatology Department. At V. S. Hospital, Dr. Shah worked with Dr. J. J. Trivedi, a biochemist at the college, who helped him get extracts from the leaf using different solvents such as chloroform, alcohol and ether. The extracts were subjected to thin layer chromatography (TLC) and column chromatography, which helped in identifying their different components. The chloroform extract was mixed with Vaseline (petroleum jelly) and the resulting ointment was put in plastic jars. As the chloroform in the extract had not completely evaporated, the residual chloroform dissolved the plastic jar and the ointment leaked.  Consequently, they discarded the chloroform extract and replaced it with an alcohol extract. Initially, the ointment was made manually. The process involved getting the extract, mixing it with Vaseline, adding fragrances and packing the final product in small aluminum tubes. They later replaced the ointment base (petroleum jelly) with cream, as cream was more convenient to use and more widely accepted. 

Unlike ointments, creams were water washable. They were made by emulsifying oily substances with aqueous ones. The techniques and chemicals used to formulate different types of creams varied; for instance, oil in a water emulsion produced washable cream, while water in an oil emulsion produced moisturising cream. Dr. Shah educated himself on these techniques for the purpose of making the cream. 

Getting a regular supply of leaves was critical for making larger quantities of the medicine for wide use.  He tried to get the leaves from various nurseries and even requested friends who lived in bungalows to plant the creeper on their properties. However, these efforts did not meet with success. Later, when he built his own bungalow, he grew the creeper in his compound and also identified traders who could supply the leaves. He dried and stored the leaves and began to look for ways to get extracts from the dried leaves.  He powdered them in a grinding machine, soaked the powder in a solvent, and separated the liquid extract from the useless insoluble parts using a manually operated juicer. He then distilled the juice to obtain a concentrate of the extract. Dr. Shah carried out all these activities in his own backyard and kitchen laboratory. Reflecting on his experiments and experiences, Dr. Shah said:

I moved from one problem to the other, and I donned new roles. I began as a doctor using a medicinal herb to treat incurable and difficult conditions. As   I pursued my enquiry, I became a technologist looking for an appropriate technique to make the extract; a scientist attempting to separate and identify various phytochemicals like alkaloids, flavonoids and glycosides that possessed distinct medicinal properties from the extract; a pharmacist  learning to make topical formulations like ointments, lotions and creams;   an operator as I tried to pack cream into aluminum tubes; and a crusader trying to convince my colleagues about the efficacy of my formulation.  In the midst of all this, I continued my clinical practice and attended to patients. From one role to the other, I learned a lot.

Experience at V. S. Hospital

Dr. Shah attempted to persuade his colleagues at V. S. Hospital to try the cream in treating difficult cases of ulcers. He found that they were reluctant to use a ‘herbal cream’. An opportunity to prove the effectiveness of the cream arose in 1978 when Dr. Vasavada, a neurophysician at the hospital, requested Dr. Shah to apply the cream on multiple ulcers on the back of a 20-year-old boy in his ward. The patient was close to dying. Dr. Shah applied the cream and the ulcers healed within a week. Nurses in the ward spread the news of the treatment's effectiveness to their colleagues, who in turn requested doctors to try ‘Dr. Shah’s herbal cream’ on patients with foul-smelling ulcers in their wards. According to Dr. Shah, the results were excellent. As the story spread, doctors in Ahmedabad were willing to try the herbal cream that was reportedly effective in treating incurable ulcers, but not  knowing  what it was called or exactly where it was available, they sent patients directly to Dr. Shah's clinic at Doctor House with slips of paper with prescriptions for ‘Doctor House ointment,’ ‘Dr. Shah’s ointment’ and ‘Bed sore ointment’.  

At V. S. Hospital, Dr. Shah kept records of patients treated for ulcers with their clinical histories and ‘before’ and ‘after’ photographs. He experimented with treating other skin conditions with the ointment.  He prepared a proforma to document the results, in which features such as infection, foul smell and size of the ulcer were given a numerical value at fixed intervals, initially after four days and then after a week. The severity index (indicating the severity of the ailment) was calculated on this basis. He instructed nurses not to give special attention to patients in the trial. Two laboratory studies were conducted in 1981 to assess the antibiotic activity and sterility of the leaf extract. The studies found that the extract showed antibiotic action against staphylococci and some other bacteria and that it was sterile. 

Dr. Shah presented his findings in a paper at the World Congress of Dermatology in Tokyo, Japan in 1982 to a widely appreciative audience. Dr. Petzoldt from Germany, the Chairman of the session, congratulated him and said, “Fantastic work, Dr. Shah, I cannot imagine how you, a clinician, can do this work.” He invited Dr. Shah to Germany to seek funding for his research, but Dr.  Shah was unable to take him up on the offer. Later, he presented papers at regional and national conferences of dermatologists, surgeons and scientists, all of which he did without having any formal training in research methods and statistics.  During this period, he was advised by his colleagues to protect his research by getting a patent. With the help of a patent attorney, he applied for a patent for the topical use of Argyreia speciosa and obtained it in 1996.    

Becoming an Entrepreneur

Describing the circumstances that led to his becoming an entrepreneur, Dr. Shah recalled:

Two resident doctors, Dr. Atul Bhatt and Dr. Khamar of V. S. Hospital, who were impressed by the unique properties of the ointment in treating difficult cases of non-healing ulcers, suggested that the cream be manufactured on a large scale and made available everywhere to needy patients. Getting into manufacturing on a large scale meant that I should become an entrepreneur. I neither had the knowledge nor funds to venture into this. 

Dr. Shah was not ready to venture into marketing or manufacturing as he did not have the wherewithal for these activities. No third-party manufacturer was prepared to work for a beginner whose product demand was limited and uncertain. The manufacturers had to adhere to drug control rules that stated that any factory could work for a maximum of six companies on a licence basis. They preferred clients who could help them earn revenue by placing large and consistent orders. Dr. Shah approached an Ahmedabad-based pharmaceutical company with a proposal that he would share the formula of the product with the company if it would manufacture and market the cream for a fee. The company did not show much interest in pursuing the proposal. 

Then, something occurred that changed the course of events. Dr. Shah said:

A chance meeting between my younger son Rajen and his friend Jaimish's father, Rasikbhai, in 1997 opened a window for entrepreneurship.  Rasikbhai was a partner in Tuton Pharmaceuticals, a third-party manufacturing company in the pharmaceutical industry.  

Jaimish, who was the Head of Tuton Pharmaceuticals, a third-party manufacturer of capsules, syrups and ointments, agreed to associate with Dr. Shah on a job work basis if Dr. Shah could provide extracts of the leaf to him. With the extract, he would manufacture the cream, pack 25 grammes of cream in aluminum tubes, place the tubes in cardboard boxes, and ready them for shipping.  To take the venture forward, Dr. Shah was required to design a brochure with the appropriate product information and market the product.  In 1998, Dr. Shah’s family members set up a company called Maya Medicines to market the product through distributors and retailers. He identified a supplier who agreed to collect the leaf, prepare the extract and supply it to Tuton Pharmaceuticals. Dr. Shah branded the cream as   Mayaderm. He developed the product brochure and prepared visual aids for medical representatives to use in product detailing to doctors. The product was priced at INR 70 for a 25 gramme tube. Dr. Shah had initially developed a consumer pack of 10 grammes priced at INR 30, which was subsequently distributed as a physician’s sample. 

The price covered the costs of leaf collection and extraction, preparation and packaging of the cream, distribution and promotion, and offered a reasonable profit. Mayaderm was launched in Ahmedabad in 1998. The distribution infrastructure involved 23 distributors and a stockist. Maya Medicines recruited 15 medical representatives and two area managers to promote the product in Gujarat. They were to visit general physicians, specialist surgeons, dermatologists and hospitals to promote the product. They were given identical briefs on the product.  They promoted the product as a herbal cream with unique properties. Dr. Shah felt that creating awareness of the product across various health care professionals was critical in view of the multiple uses of the cream. The medical representatives noted that the doctors they met respected Dr. Shah and conveyed their regards to him. Because of Dr. Shah’s reputation, they did not have to spend much time convincing the doctors about the product's efficacy. Despite this, for reasons unknown to Dr. Shah, all the medical representatives resigned from the company in 2001. He then relied on sales generated through word-of-mouth publicity based on the cream's past effectiveness and the goodwill he had earned within the medical fraternity. The distribution of the product was assigned to an established stockist of pharmaceutical products in Gujarat. His responsibility was to stock and send the product to distributors and retailers for sale to end-users.

Feedback from Doctors  

Dr. Shah received letters from doctors stating that they prescribed the ointment for various skin-related ailments for which the prevailing treatment was ineffective. They identified new uses of the ointment in treating bed sores, trophic ulcers in leprosy, gangrene in diabetics, fissures, leg ulcers, minor and major burns, minor to major accidental wounds and skin conditions such as chronic folliculitis, boils, cellulitis,  pimples and chickenpox.  Mayaderm was found to be useful as a single remedy or as a co-prescription.  Another new use for Mayaderm was in treating pemphigus, an autoimmune condition in which the patient had to take steroids for life and suffered serious side effects. Dr. Shah pointed out that no easy and effective or affordable treatment was available anywhere in the world;  however, Mayaderm was effective in treating this disorder. 

Based on the feedback from doctors and further insights into the healing properties of the extract, Dr. Shah prepared different formulations from the extract to treat leucorrhoea, anorectal itching, cracked heels, nasal ailments and nail diseases.  He developed liquid formulations for nail and ear disorders (e.g. ear drops) and dispensed them from his clinic.  He treated a difficult case of ‘red eye,’ which eye doctors had been unsuccessful in treating, with drops made from the leaf. 

Further Laboratory Studies

Dr. Shah felt that he needed to prove the sterility and antibacterial activity of the extract and its efficacy and safety in treating animals and human beings. The extract's sterility and antibacterial activity was tested in a private research laboratory. On May 3, 2001, Dr. Shah contacted Professor Harish Padh, Director of B. V. Patel Pharmaceutical Education and Research Development Centre at Ahmedabad and requested him to investigate the safety and wound-healing properties of the cream. The trials on animals and humans were conducted during January and March 2002.  The total cost of these tests was Rs 10,000.  The results indicated that the cream was safe for use.  Further tests on wound healing quality were conducted in April and May of 2004. The cost of these tests was  INR 18,000. Dr. Shah paid for these tests from personal funds.  Competition

Small, medium and large companies that produced herbal and chemical formulations for treating skin disorders were Mayaderm's logical competitors. Herbal companies consulted Ayurvedic texts to identify a winning formula for making their skin creams. Pharmaceutical companies relied on chemical-based laboratory tests and clinical trials to prove the validity of their products and increase their relevance in the market. They had a network of distributors and their medical representatives detailed their products to doctors and generated prescriptions. Some of their brands were advertised on national television and in newspapers. The prominent players in this segment were G. D. Pharmaceuticals Limited and Vicco Laboratories Limited.  G. D. Pharmaceuticals, established in 1929, sold an antiseptic cream under the brand name Boroline, while Vicco Laboratories was formed in 1952 to manufacture and market products based on Ayurveda. Its popular products were Vicco Turmeric Ayurvedic Cream and Vicco Vajradanti tooth powder and toothpaste. Both companies promoted their products through television and print media. They had nationwide distribution networks.  Paras Pharmaceuticals Limited, set up in Gujarat in 1980, offered powders for prickly heat and creams for treating cracked heels, itching and ringworm. It was acquired by Reckitt Benckiser Group plc, a diversified multinational with business interests in home and hygiene products  Dr. Shah noted that large pharmaceutical companies had also begun venturing into herbal medicines. For example, Cadila Pharmaceuticals Limited, an Ahmedabad-based company set up in 1951, had a division that produced herbal formulations based on Ayurveda for hair and skin care and for treating mouth ulcers and sores.  

Despite the number and variety of herbal creams in the market, Dr. Shah believed that there was no competing product to Mayaderm in the market, given its unique set of medicinal properties such as dissolving slough, stimulating the production of healthy granulation tissue and promoting the formation of new skin. His product was one of its kind. It had the potential to treat multiple ailments for which effective and affordable treatments were not available. It could be used not only by individual patients at home but also by doctors in hospitals. 

Dr. Shah’s Question

In 2012, Dr. Shah gave non-exclusive marketing rights for Mayaderm to Atra Pharmaceuticals to promote the cream nationally. Atra Pharmaceuticals was set up in 1995 to manufacture pharmaceutical products on a contract basis.  Over the years, it diversified into the production and sale of generic products, herbal formulations and pharmaceutical intermediaries. The company increased the price of Mayaderm from INR 70 to INR 120 per tube and launched it nationally. According to Dr. Shah, the product was received well in markets across India.  By the middle of 2013, 20,000 tubes of Mayaderm had been sold. Dr. Shah mentioned that , doctors continued to prescribe the cream but retailers and chemists were not able to honour the prescriptions as they often did not have the medicine in stock. He believed this was because of the absence of representatives who could ensure that retailers stocked the product. 

Dr. Shah contacted leading pharmaceutical companies in Ahmedabad to gauge their interest in buying the technology for the product and launching it under their own name. They were reluctant to invest in the technology and the product. Still, Dr. Shah was optimistic about commercialising his innovation so that it could reach people everywhere. The medicinal properties of the cream were proven and the feedback from doctors and patients on the performance of the product was positive. Further, Dr. Shah noted that antiseptic and antibiotic ointments worth billions of dollars were used for treating ulcers and wounds irrespective of whether they were effective or not. According to him, the market was large enough to support Mayaderm, but what it lacked was effective marketing support. However, his entrepreneurial venture was not as profitable as he expected it to be. It should have earned a net margin of at least 30% after meeting all costs. He was looking for an appropriate way forward. 

Exhibit 1 : Description of Mayaderm

Source: Document provided by Dr. Shah.

Exhibit 2: Profile of Dr. C. F. Shah

Birth Date: January 13, 1924

Current Position

• Senior Practising Dermatologist since 1951

• Professor Emeritus, K. K. School of P.G. Medicine and Research

• Managing Trustee, Herbal and Ayurvedic Research Institute (HARI)

• Member, Society for Promotion of Ayurvedic Consciousness (SPAC)

Professional Experience

• Former Professor of Dermatology at:

• Civil Hospital B.J. Medical College, 1951-66

• V.S. Hospital & N.H.L. Medical College, 1966-83

• Honorary Advisor for Clinical Research Inquiry, Central Council of Indian Medicine and Homeopathy, 1978.

• Former member, Governing Council Association of Ayurveda Development Research (AADAR).

Association Activities

• Past President, Ahmedabad Medical Association

• Past President, Association of Occupational Health

• Joint Secretary, All India Medical Conference,  1970

• Treasurer, National Conference of the Association of Physicians of India (API)

• Former President, Indian Association of Dermatologists, West India, 1978.

Research & Academics

• Patent for Argyreia speciosa, active agent in Mayaderm, a wound healing ointment, and Maya Mouth Gel for conditions of the mouth.

• Patent for anti-pruritic paint (APP), a topical formula for itching 

• Presented several papers at state-level, national and international conferences.

• Published several research papers in professional journals.

Awards

• Dr. Shirwalker Junior Clinical Surgery Gold Medal, K.E.M. Hospital, Bombay.

• Key of Allentown, Pennsylvania (United States), given by the Mayor, 1982.

• Scroll of Honor, Academy of Ayurveda Development and Research (AADAR).

• Certificate of Excellence, India’s Best Doctor, Medgate.

• Sigma Excellence in Health Care, Lifetime Achievement Award.

Social Activities

• Secretary, Shree Mahavir Jain Vidyalaya Students Union, Mumbai, 1942.

• Member, Shree Mahavir Jain Vidyalaya, Ahmedabad, Local Executive Committee.

• Member, Freemason Postmaster, Lodge Fellowship since 1960. This is an international organisation.

• Member, Jain Doctors’ Federation

• Honorary Consultant, Acworth Leprosy Hospital 

• Honorary Visiting Consultant, Rasikbhai Shah Hospital, Modasa. 

Source: Based on discussions with Dr. Shah and his personal documents.